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Vifor Pharma

Die Vifor Pharma Gruppe – die frühere Galenica Gruppe – ist ein globales Spezialitäten-Pharmaunternehmen, das eigene Pharmaprodukte erforscht, entwickelt, herstellt und vertreibt und ein bevorzugter Partner für innovative patientenorientierte Lösungen ist.
Das Unternehmen hat sich zum Ziel gesetzt, ein globaler Marktführer in den Bereichen Eisenmangel, Nephrologie und kardiorenale Therapien zu sein und weltweit Patienten mit schweren und chronischen Erkrankungen zu einem besseren Leben in Gesundheit zu verhelfen.
Die Vifor Pharma Gruppe verfügt über Produktionsstätten in der Schweiz und in Portugal sowie über ein dynamisches Netzwerk von Vertriebsgesellschaften und Partnern zur weltweiten Marktabdeckung. Das Unternehmen treibt die Expansion seiner weltweiten Präsenz laufend voran, bleibt dabei aber in seinem schweizerischen Heimmarkt fest verwurzelt.

Vifor Pharma

Flughofstrasse 61
8152 Glattbrugg

20.08.2019

Vifor Pharma

Clinical Trial Educator - Germany, Home-based

  • Vifor Pharma

  • Germany - Field based

  • 20.08.2019

  • Vollzeitstelle

We are currently looking for a Clinical Trial Educator (CTE), being located in Germany. In this position, you will report to the CTE Team Lead and will be part of the global Clinical Operations team. The CTE is responsible for supporting Vifor-sponsored clinical trials, through CRO oversight and interaction with investigational sites, within the assigned countries/territory. You will contribute to and support successful execution of clinical trial protocols and work as a cross-functional matrix team member. Your tasks will include, but not be limited to, the following:Establish relationship with investigational sites and act as sponsor interfaceChampion site specific recruitment plan and strategies, mitigate barriers to patient recruitment with stakeholders Interact with Vifor Pharma’s global Clinical Study Team, Vifor Pharma’s local medical staff, external Service Providers, and investigational site staff (including investigators and study coordinators) to assist with timely, efficient and high quality trial delivery throughout all stages of the studySupport operational excellence of global clinical trials through CRO oversight activities, including but not limited to accompanied visits, monitoring report review, tracking of trial related metrics and input to respective project plansAd-hoc member of the global Clinical Study TeamProvide input into department SOPs and processes, and involvement into investigational site inspection and audit readiness activitiesFor this role we are looking for a flexible and efficient person bringing the following profile:Relevant University Degree (BSc) or Health Care Degree (e.g. RN) with a higher degree (e.g. PhD, MD, PharmD) being preferredMinimum of 5 years in the pharmaceutical industry, in a Senior Clinical Research Associate (CRA) or Lead CRA role, including direct contact with study sites and KOLsGood understanding of the drug development process and clinical trial executionFamiliar with clinical trial documentation and regulatory requirementsExcellent knowledge of ICH GCP requirementsExcellent user of Office Programs (Word, Excel, PowerPoint)Fluency in German and EnglishFluency in Polish is a plusWillingness to travel (65% local and international travel required)You bring excellent verbal and written communication and presentation skills. You are able to interact professionally and productively and to convince others. You are able to coordinate and complete activities across multiple functions. You are a team player, working well in cross-functional teams, but also being able to work independently, and execute tasks with minimal oversight. You take a thorough approach with high attention to detail and display strong organisational and time management skills. You have high ethical standards and integrity.
Inserat ansehen

09.09.2019

Vifor Pharma

Field Medical Advisor – Region Middle Switzerland

  • Vifor Pharma

  • Switzerland - Field based

  • 09.09.2019

  • Vollzeitstelle

Due to the expansion of our global business, we are looking for new medical affairs team members with a field focus working as Field Medical Advisor to develop the Middle Region of Switzerland. In this function, you represent Medical Affairs externally; establishing and maintaining medical relationships with Key Opinion Leaders (KOLs), HCPs and key accounts on behalf of Vifor Pharma Group. You develop and execute the country medical plan, through scientific engagement with the medical community. You are responsible for the following tasks:Develop and maintain scientific and medical expertise (Cardiology and Nephrology and corresponding products)Identify, develop and maintain relationships with KOLs, HCPs and professional organizationsKOL scientific engagement, key account medical support, training and medical information Update medical team and other internal stakeholders on medical community interactions Provide medical support to market access activities following global and local policies and proceduresSupport the development, implementation and completion of medical activities (advisory boards, congress symposia, hospital meetings and speaker programs)Provide Disease State Education, clinical presentations and respond to medical requestsServe as a medical resource for internal medical and sales trainingSupport company sponsored clinical research and IIS process Attend relevant scientific meetings and conferences and support development of summaries of key data, presentations or symposiumEnsure compliance with applicable local and global laws, regulations, guidelines and company policies and proceduresDevelop personal and professional capabilities to improve skills and professional capabilitiesWe are looking for an experienced and enthusiastic candidate bringing the following profile:Master or PhD in Scientific Field (e.g. Pharmacy, Medicine, biochemistry or Biology)Minimum of 3 years’ experience in clinical practice, research or pharmaceutical medical affairsMinimum of 5 years’ experience with pharmaceutical industry and healthcare compliance requirements locally and globallyPrevious experience as Field Medical Advisor or Medical Scientific Liaison is preferredExperience in therapeutic area(s) Cardiology and/or Nephrology is a plusDemonstrated experience in KOL, HCP or medical community engagementExcellent oral and written communication skills in German and very good oral and written communication skills in English. Knowledge in French is an assetYou live in the region you work for and enjoy working field based with customers Willingness to travel for international congresses and/or boarder country congresses Your ability to work well within a team ensures your success within a collaborative environment. Your expert medical knowledge enables your ability to establish and maintain strong relationships with KOLs and other key stakeholders. You are a positive, solution-driven and result-oriented person that likes to work in an entrepreneurial environment, where you can make the difference.
Inserat ansehen

09.09.2019

Vifor Pharma

Field Medical Advisor – Region Eastern Switzerland

  • Vifor Pharma

  • Switzerland - Field based

  • 09.09.2019

  • Vollzeitstelle

Due to the expansion of our global business, we are looking for new medical affairs team members with a field focus working as Field Medical Advisor to develop the Eastern Region of Switzerland. In this function, you represent Medical Affairs externally; establishing and maintaining medical relationships with Key Opinion Leaders (KOLs), HCPs and key accounts on behalf of Vifor Pharma Group. You develop and execute the country medical plan, through scientific engagement with the medical community. You are responsible for the following tasks:Develop and maintain scientific and medical expertise (Cardiology and Nephrology and corresponding products)Identify, develop and maintain relationships with KOLs, HCPs and professional organizationsKOL scientific engagement, key account medical support, training and medical information Update medical team and other internal stakeholders on medical community interactions Provide medical support to market access activities following global and local policies and proceduresSupport the development, implementation and completion of medical activities (advisory boards, congress symposia, hospital meetings and speaker programs)Provide Disease State Education, clinical presentations and respond to medical requestsServe as a medical resource for internal medical and sales trainingSupport company sponsored clinical research and IIS process Attend relevant scientific meetings and conferences and support development of summaries of key data, presentations or symposiumEnsure compliance with applicable local and global laws, regulations, guidelines and company policies and proceduresDevelop personal and professional capabilities to improve skills and professional capabilitiesWe are looking for an experienced and enthusiastic candidate bringing the following profile:Master or PhD in Scientific Field (e.g. Pharmacy, Medicine, biochemistry or Biology)Minimum of 3 years’ experience in clinical practice, research or pharmaceutical medical affairsMinimum of 5 years’ experience with pharmaceutical industry and healthcare compliance requirements locally and globallyPrevious experience as Field Medical Advisor or Medical Scientific Liaison is preferredExperience in therapeutic area(s) Cardiology and/or Nephrology is a plusDemonstrated experience in KOL, HCP or medical community engagementExcellent oral and written communication skills in German and very good oral and written communication skills in English. Knowledge in French is an assetYou live in the region you work for and enjoy working field based with customers Willingness to travel for international congresses and/or boarder country congresses Your ability to work well within a team ensures your success within a collaborative environment. Your expert medical knowledge enables your ability to establish and maintain strong relationships with KOLs and other key stakeholders. You are a positive, solution-driven and result-oriented person that likes to work in an entrepreneurial environment, where you can make the difference.
Inserat ansehen

14.08.2019

Vifor Pharma

Field Medical Advisor –Switzerland

  • Vifor Pharma

  • Switzerland - Field based

  • 14.08.2019

  • Vollzeitstelle

Due to the expansion of our global business, we are looking for new medical affairs team members with a field focus working as Field Medical Advisor for scientific management of products in the field of percutaneous coronary interventions and cardiovascular surgery. In this function, you represent Medical Affairs internally and externally; establishing and maintaining medical relationships with Key Opinion Leaders (KOLs), HCPs and key accounts on behalf of Vifor Pharma Group. You are responsible for the following tasks:Develop and maintain scientific and  medical expertise (Cardiology, Nephrology, Anesthesiology and corresponding products)Identify, develop and  maintain relationships with KOLs, HCPs and professional organizationsProvide Disease State Education, clinical presentations and respond to medical requests (internally and externally)Organization of medical activities (advisory boards, congress symposia, hospital meetings and speaker programs)Planning, implementation and support of ongoing projects as well as new projects such as clinical studies and registries Reading and evaluation of relevant specialized literatureStrategic contribution to Brand Teams in collaboration with the marketing Medical support to the marketing department during the creation of promotional materialEnsure compliance with applicable local and global laws, regulations, guidelines and company policies and proceduresDevelop personal and professional capabilities to improve skills and professional capabilitiesWe are looking for an experienced and enthusiastic candidate bringing the following profile:Master or PhD in Scientific Field (e.g. Pharmacy, Medicine, biochemistry or Biology)Professional experience in the health sector or the pharmaceutical industry is essentialDemonstrated experience in KOL, HCP or medical community engagementAs a native French or German speaker, you have a perfect command of the other language, both in oral and written conversation. Good knowledge of English is also desirable.Willingness to travel for international congresses and/or boarder country congresses Your ability to work well within a team ensures your success within a collaborative environment. Your expert medical knowledge enables your ability to establish and maintain strong relationships with KOLs and other key stakeholders. You are a positive, solution-driven and result-oriented person that likes to work in an entrepreneurial environment, where you can make the difference.
Inserat ansehen

06.09.2019

Vifor Pharma

Délégué Médical en Médecine Générale 80 - 100% (h/f) – Région Suisse Romande

  • Vifor Pharma

  • Switzerland - Field based

  • 06.09.2019

  • Vollzeitstelle

En raison d'un futur départ en retraite, nous recherchons un/une Délégué/e Médicale à 80% ou à 100%. A ce poste, vous travaillez au sein du service externe et êtes responsable de la commercialisation des produits Rx dans le domaine de la médecine générale pour les régions de Genève / Jura / Neuchâtel. Vos missions principales consistent à :Visiter et conseiller les médecins généralistes Développer le portefeuilles clients et assurer le suivi de la clientèle existanteDévelopper et consolider les relations avec les Opinion Leaders (KOLs)Réaliser les objectifs de venteAnalyser régulièrement les données de ventes de votre territoire, définir et mettre en œuvre des mesures appropriéesObserver et suivre l’évolution du marché et de la concurrenceOrganiser des événements : tables rondes, formations continues, symposia Participer aux congrès nationaux et internationaux, aux meetings de vente ainsi qu’aux formations internesAfin d’assurer au mieux ces fonctions, nous recherchons une personne dynamique et autonome disposant du profil suivant:Formation dans le domaine médical ou paramédicalLe diplôme Fédéral SHQA comme Délégué Pharmaceutique est un atoutPlusieurs années d’expérience professionnelle dans la délégation médicaleD’excellentes compétences en matière de négociation et de communicationAisance avec les outils IT tels que MS-Office tools et CRMDe langue maternelle française, vous possédez également de bonnes connaissances en allemand et en anglaisVous êtes une personne flexible et appréciant le travail en équipe. Vous êtes également capable de vous organiser de manière indépendante et de faire face à des situations de stress. Vous aimez et savez convaincre tout en inspirant autrui par votre enthousiasme. D’un naturel orienté objectifs, vous atteignez le succès en respectant nos principes d’éthique. Pour pouvoir garantir le meilleur suivi possible de vos clients, votre lieu de résidence se trouve dans la région concernée par le poste.
Inserat ansehen

13.09.2019

Vifor Pharma

Regulatory Affairs Manager - LATAM - Zurich

  • Vifor Pharma

  • Switzerland - Glattbrugg/Zurich

  • 13.09.2019

  • Vollzeitstelle

We are currently looking for an experienced Regulatory Affairs Manager with focus on the Latin America markets to join our team. You will be responsible for the creation and implementation of robust regulatory strategies for the assigned portfolio based on the good knowledge and appropriate interpretation of guidelines and directives. Based in our Operational Headquarters in Glattbrugg, you will report to Head of Regulatory Affairs Partner Business Central & Eastern Europe & Latin America and your responsibilities will include: Keep up to date with the latest regulatory requirements in Latin AmericaCreate robust regulatory strategies based on the good knowledge and appropriate interpretation of the relevant guidelines and directivesAct as single point of contact between Regulatory Affairs of the partner company, regional regulatory representatives of Vifor Pharma Group and corporate or regional stakeholdersPlan all regulatory activities with the Regional Regulatory Affairs, partner companies and other Global Regulatory Affairs functions and ensure timely executionBe accountable for successful dispatch and submission of new marketing authorisations, and for effective and compliant regulatory life cycle management (variation, extension applications etc.) for the assigned portfolio in the regionEnsure compliance of regulatory dossiers with legal requirements in close collaboration with other functions of Global Regulatory Affairs such as the Therapeutic Groups, Labelling, Operations and CMCDrive the approval processMaintain the assigned Regulatory Databases according to internal guidelinesManage the preparation of the responses to Health Authority questions / requests for informationManage product labelling information updates in accordance with the company and regional requirementsCooperate with internal stakeholders such as Global Drug Safety, Quality, and other departments to ensure compliance and alignment with agreed partner support levelsThe successful candidate will bring a degree in Life Sciences, Pharmaceutical Sciences or equivalent and fulfil the following criteria:Minimum 5 years of experience in Regulatory Affairs Ability to analyse the regulatory requirements (regulatory, quality and safety guidelines), perform comprehensive gap assessments and build effective regulatory strategiesProject and matrix team management capabilities (direct/indirect people management experience and experience in the global roles/matrix teams is an advantage)Excellent communication and negotiation skills at all levels, and discretion in the handling of confidential informationSuccessful track records of new products registration in LATAM region, exposure to orphan products, experience with RA Labelling and regulatory information management systems implementation/key user exposure would be considered as a plusBusiness fluency in English. Command of regional (Spanish, Portuguese) and/or manufacturing sites (German) languages is an advantageYou are a mature regulatory professional, open to new projects and challenges, willing and capable to shape your environment, to setup and to improve work processes, and to influence internal and external stakeholders. You are a strategic thinker with good analytical skills and result-oriented mindset. Your excellent project management skills will ensure your success in this role. You act as a role model for others in line with Vifor Pharma values.
Inserat ansehen

30.08.2019

Vifor Pharma

IT Security Expert - Architecture and Operations - Zurich

  • Vifor Pharma

  • Switzerland - Glattbrugg/Zurich

  • 30.08.2019

  • Vollzeitstelle

We are seeking an IT security professional who will be based at our operational headquarters in Zurich. Responsible for continuous improvement of Group security landscape and reduction of security risk exposure. Providing technical security consultancy and requirements to projects and internal stakeholders. Advising and supporting the business and IT in implementing IT security requirements and promoting desired behavior in regard to security awareness through trainings etc. Reporting directly to the IT Security Officer, your tasks and responsibilities will include, but not be limited to, the following:Define security requirements and review of IT projects and architecturesReview and support the enhancement of security policies, standards and proceduresAssess security risks and identify appropriate mitigation actionsPerform internal technical security verifications, assessments, and threat huntingProvide incident response / support to IT teams during security incidents. Investigate suspected security incidents, recommend and coordinate corrective actionsProvide on-call services when needed for incidentsCollaborate and negotiate effectively with external partners and perform vendor risk assessmentsSupport the continuous security monitoring and protection of IT systemsParticipate in the development, operations, and improvement of security technologies, related tools and processesContribute to security reports, dashboards and alerts to create an overall situational awareness of the threats Assist in the review of applications and/or technology environments acquisition and/or procurement of new applications or technologiesOwnership of IT security operation projects to further develop security systems (e.g. security monitoring, data leakage prevention, network security)The ideal candidate is an IT Security professional with the following essentials skills and experience:A degree in Security/IT/Engineering or relevant experienceRecognised professional security certification (e.g.: SSCP, CISSP, GIAC) or comparable experienceProven experience in Security Operation analysis, identifying, monitoring and controlling with at least 3 years on hands-on security incident handling and coordinationExcellent knowledge of securing IT infrastructure with respect to information security concernsDemonstrated experience in IT security architectures design and assessmentsDeep knowledge of IT security in areas such as system security, incident response, forensics, security monitoring management, and application securityKnowledge and experience with Information Security Frameworks (e.g.: ISO27001, NIST) and best practices in security engineering: network security, security operations, systems security, policies, and incident responseFluent level in English (in oral and written communication)The following skills would be advantageous:Experience as pentester Negotiation and project management skills Knowledge of regulated environments (GxP) Additional languages You have excellent analytical and problem-solving skills, hands-on working style, reliable, autonomous, proactive, solution oriented mindset, team player fostering good working atmosphere and showing a strong interest in information security. You are strong in communicating complex and sensitive topics on both, business and technical staff levels. You have very good networking skills and a broad professional network. You have understanding of business requirements and technology to support business objectives. You are able to work on different projects and activities simultaneously. You act as a role model for others in line with Vifor Pharma values.
Inserat ansehen

12.09.2019

Vifor Pharma

Head of Regulatory Affairs (one Therapeutic Area) - Zurich

  • Vifor Pharma

  • Switzerland - Glattbrugg/Zurich

  • 12.09.2019

  • Vollzeitstelle

We are currently hiring a Head of Regulatory Affairs (one Therapeutic Area) in our global RA team. In this role you will be the deputy to the Head Global Regulatory Affairs for specific projects; and therefore a key leader in our growing team as we aim to further build and strengthen Vifor Pharma’s reputation as a star amongst Swiss specialty pharmaceutical companies.You will be responsible for the following tasks:Manage a Therapeutic RA team on designated regulatory projects in compliance within respective project plans and timelinesLead GRA processes for assigned projects with timely strategic input in support of coordinated registration activities in EU, US, CH, AU, CN & JPReview and approve global regulatory strategies & submissions, as well as company contributions to policy consultation or legal proceedingsMonitor, analyze, and anticipate changes in the regulatory environment, implement necessary adjustments to strategies or contentRepresent the Global Regulatory Affairs (GRA) function at key global health authority meetings and with external stakeholdersLeverage regulatory health authorities (e.g. FDA, EMA, key national competent authorities), industry trade associations’, and other relevant organizations’ insights to advance Vifor’s position related to regulatory and safety policyProvide strategic Regulatory leadership either directly or via mentoring and guidance of team members:Guidance to internal brand, product and project teams on strategy, LCM, data requirements and label development  Planning for new development and new registration activities in regions of responsibilityStrategy input into integrated development plans enabling optimal product launch and market access. Provide support and act as deputy of Head of GRA for specific projectsTake on specific strategic and organizational responsibilities in consultation with Head Global Regulatory Affairs Functional representative to designated governance committees as assigned (e.g. PRC, DRRB, DSB, GCC)For this role we are looking for the following requirements:BS, BA in a relevant scientific discipline, or BSN/BSc in Nursing, however MA/MS or PhD in life sciences or chemical engineering, or PharmD preferredAt least 12 years’ experience in Pharmaceutical IndustryExperience with both biosimilars / generics and innovative products would be a big advantageDemonstrated organisational leadership, combined with diplomacy, and an ability to build effective working relationships at all levels throughout the organization to achieve business goalsDirect experience interacting with national Health Authorities and knowledge of the process for developing and launching productsFundamental understanding of the contents of product dossiers and critical attributes of medicinal products for registrationExcellent verbal and written communication skills in EnglishStrategic thinker, planner, and implementer with a proven track record practicing sound judgment
Inserat ansehen

20.08.2019

Vifor Pharma

Clinical Quality Systems Specialist - Zurich

  • Vifor Pharma

  • Switzerland - Glattbrugg/Zurich

  • 20.08.2019

  • Vollzeitstelle

We are currently looking for a Clinical Quality Systems Specialist who will be based in our Operational Headquarters in Zurich. The Clinical Quality Systems Specialist will be an integral part of the Clinical Quality Assurance (CQA) function, supporting the quality systems. The primary focus of this role is the management of SOPs within the electronic records management system. This position will also support the Learning Management System activities, assist with regulatory inspection readiness, inspection management and CAPA. Your tasks and responsibilities will include, but not be limited to the following:Maintain and support Clinical Quality SOP related Systems servicing Clinical Development and Biometrics, Medical Affairs, Regulatory Affairs and Drug SafetySOPs administration: review and approval workflow management, SOP editing , SOP lifecycle /ongoing review managementStakeholders / Author support and trainingElectronic Records managementProcess improvementCompliance check of SOP content against applicable regulations and related SOPsSupport clinical quality training and related systemsProvide support in regulatory inspectionsMonitor department CAPA execution to ensure accuracy and completenessRepresent CQA in assigned projects and cross functional groupsKeep CQA management apprised of processes and system status and compliance issues through periodic reports and KPIsThe ideal candidate will ideally bring the following skills and experience:Undergraduate degree in life sciences or equivalent3-5 years in pharmaceutical industry / CRO with SOP management experienceAbility to independently manage processes within electronic quality management systems (SOPs, LMS, e-docs)Strong knowledge and understanding of GCP and GVP regulationsFluency in spoken and written English (advanced / mother tongue level for written English), any other language is an advantageProficiency in the use of relevant computer systems including complete Microsoft office suite (Visio and MS Project included)Experience with regulatory inspections and inspection readiness (preferred)Ready to travel, as some travel is required (up to 10%)You have strong interpersonal, written and oral communication skills at all levels and are able to build partnerships and diplomatically work with other departments. You have «can do» attitude, are a team player and act as a role model for others in line with Vifor Pharma values.
Inserat ansehen

11.09.2019

Vifor Pharma

Therapeutic Area Lead - Zurich

  • Vifor Pharma

  • Switzerland - Glattbrugg/Zurich

  • 11.09.2019

  • Vollzeitstelle

We are currently looking for a Therapeutic Area lead to join our Global Drug Safety and Risk Management Team. In this leadership role you will be reporting directly to the Global Head of Medical and Clinical Drug Safety, you will be responsible to ensure the scientific foundation of the Benefit-Risk profile of our products as well as the compliance of company drug safety. Your tasks and responsibilities will include, but not be limited to, the following:Manage the review of worldwide reports on adverse events including confirming company causality assessmentsManage the timely authoring of high quality aggregate safety reports Support the Regulatory department with evaluation of adverse event profiles of products to update regulatory documentsSupport and deliver safety trainings for new staff, pharmacovigilance staff as well as refreshersImplementation of documentation necessary for pharmacovigilance like Risk Management Plans, etc. Ensure safety tasks in clinical trials (incl. protocol review, SUSAR, ASR/DSUR, safety reporting, informed consent forms, unblinding) are handled appropriately and in compliance with regulationsProvide support in checking or preparing expert reports as appropriate and preparing safety regulatory filesSignal detection and benefit/risk evaluation including initiating appropriate measures e.g. preparing safety board presentations, change control of SmPC, updating risk management plan and resulting actions plansActive involvement in PASS or other safety studiesCreation/authoring of Medical / Clinical Safety related SOPsThe ideal candidate holds an M.D. degree in addition to the following experience: Medical Degree, ideally clinical experience as Specialist in Internal Medicine, Cardiology or Nephrology or equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safetyExperience with Benefit-Risk profile process implementation and monitoring Experience in leading a team of Drug Safety Physicians or Scientists or proven line management experienceExperience in data analysis, signal management and Benefit-Risk evaluation for at least 5 yearsExcellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations)Fluency in EnglishExperience in Pharmaceutical Medicine development, particularly Clinical Research, Clinical Pharmacology, and PharmacoepidemiologyDemonstrated ability to set up and implement drug safety strategies, risk management plans, develop Drug Safety systems and procedures, and elevate and resolve issues for both post-marketing medicines as well as medicines in clinical development (particularly dossier submission). Demonstrated proficiency in problem-solving with respect to pharmaceutical Drug Safety issuesExperience with Health Authority inspections (EMA, FDA, other) Good computer literacy with experience with safety data bases (Aris G preferably) and IT affinityCapable of exercising oversight in professional communications and problem solving liaisons with internal and external customers at senior level Capable of exercising oversight in the understanding of Drug Safety issues with Clinical team members and ensure appropriate training through workshops, seminars, courses, literature, or other means consistent with Drug Safety developmentExperience of or capable of lecturing at international drug safety conferencesYou bring very good scientific, pharmaceutical and medical knowledge. You have excellent verbal and written communication skills as well as demonstrated leadership skills and are able to become quickly a valued and esteemed senior member of our interdisciplinary teams. You are able to build and maintain good relationships with a strong customer focus.  You will professionally and successfully represent the company on the Benefit-Risk related matters in front of Health Authorities or other important external organisations or events. Your attitude and behaviour is congruent with the company values. You show concern for standard and take a thorough approach, with high attention to detail. You are interpersonally aware and culturally sensitive, with the ability to work in highly networked organisations with many partners. You are effectively able to plan and prioritise workload, with an accurate sense of urgency. You are able to interpret and apply global drug safety regulations and demonstrate a proactive attitude and build a well-functioning team with high quality output in good team spirit.
Inserat ansehen

28.08.2019

Vifor Pharma

Drug Safety Lead - Zurich

  • Vifor Pharma

  • Switzerland - Glattbrugg/Zurich

  • 28.08.2019

  • Vollzeitstelle

We are currently looking for a Drug Safety Lead to join our Global Drug Safety and Risk Management Team. Reporting directly to the Therapeutic Area Lead of Medical and Clinical Drug Safety, you will be responsible to ensure compliance of company drug safety. Your tasks and responsibilities will include, but not be limited to, the following:Manage the review of worldwide reports on adverse events including confirming company causality assessmentsManage the timely authoring of high quality aggregate safety reports Support the Regulatory department with evaluation of adverse event profiles of products to update regulatory documentsSupport safety trainings for new staff, pharmacovigilance staff as well as refreshersImplementation of documentation necessary for pharmacovigilance like Risk Management Plans, etc. Ensure safety tasks in clinical trials (incl. protocol review, SUSAR, ASR/DSUR, safety reporting, informed consent forms) are handled appropriately and in compliance with regulationsProvide support in checking or preparing expert reports as appropriate and preparing safety regulatory filesSignal detection and benefit/risk evaluation including initiating appropriate measures e.g. preparing safety board presentations, change control of SmPC, updating risk management plan and resulting actions plansActive involvement in PASS or other safety studiesCreation/authoring of Medical / Clinical Safety related SOPsThe ideal candidates holds an M.D. degree in addition to the following experience: Medical Degree, ideally Specialist in Internal Medicine or Pharmaceutical Medicine / PhD or equivalent with experience in International Drug Safety, ideally operational as well as clinical drug safetyOr Pharma experience with university background with link to health care or patient health and scientific interest Experience in data analysis, signal detection and benefit/risk evaluationExcellent knowledge of international regulations (ICH, GVP/Volume 10, FDA regulations)Fluency in EnglishExperience in Pharmaceutical Medicine, particularly Clinical Research, Clinical Pharmacology, and PharmacoepidemiologyDemonstrated ability to set up and implement drug safety strategies, risk management plans, develop Drug Safety systems and procedures, and elevate and resolve issuesDemonstrated proficiency in problem-solving with respect to pharmaceutical Drug Safety issuesGood computer literacy with experience with safety data bases (Aris G preferably)Capable of exercising oversight in communications and problem solving liaisons with internal and external customersCapable of exercising oversight in the understanding of Drug Safety issues with Clinical team members and ensure appropriate training through workshops, seminars, courses, literature, or other means consistent with Drug Safety developmentYou bring very good scientific, pharmaceutical and medical knowledge. Your positive, optimistic attitude and behaviour is congruent with the company values. You show concern for standard and take a thorough approach, with high attention to detail. You can think and influence conceptually, strategically and rationally. You are interpersonally aware and culturally sensitive, with the ability to work in highly networked organisations with many partners. You are able to actively participate and contribute to an interdisciplinary team. You have excellent verbal and written communication skills. Affinity to IT would be an advantage. You are effectively able to plan and prioritise workload, with an accurate sense of urgency. You are able to interpret and apply global drug safety regulations and demonstrate a proactive attitude.
Inserat ansehen

27.08.2019

Vifor Pharma

Receptionist - 30% (100% in Vertretung) - St. Gallen

  • Vifor Pharma

  • Switzerland - St Gallen

  • 27.08.2019

  • Vollzeitstelle

Wir suchen eine erfahrene Empfangsperson für 1.5 Tage pro Woche fix (30%; Donnerstagnachmittag und Freitag ganzer Tag) und für zusätzliche Urlaubs- / Krankheitssubstitution (100%). Als erster Ansprechpartner bei Vifor Pharma wären Sie für folgende Aufgaben verantwortlich:Entgegennahme und Weiterleitung aller AnrufeBesucher empfangen und intern anmelden (Eintragung neuer Besucher im Access, Ein- und Austragung im Visitorbook)PostverwaltungÜberwachung und Bedienung des Haupttores und des DrehkreuzesFührung der AbwesenheitslisteHerausgabe von Besucher-Legic / monatliche Legic-KontrollePIN im Interflex erfassen/löschenHerausgabe und Kontrolle der technischen Geräte für die SitzungszimmerGestaltung Media-CenterDruckerpatronen avisieren und für MA bereitstellenBüromaterial (Flipcharts) verwaltenDiverse administrative Aufgaben (Werkstattaufträge etc.)Administrative Unterstützung bei Events und WorkshopsVerfügbarkeit zu 100% für Vertretung des anderen EmpfangsmitgliedesWir suchen eine erfahrene Rezeptionistin, die das Unternehmen mit Leidenschaft gegenüber internen und externen Stakeholdern vertritt. Deshalb suchen wir eine Person mit folgendem Profil:Erfahrung als RezeptionistinSehr gute Deutsch-, Englisch- und FranzösischkenntnisseTeamfähigkeitAusgeprägte KundenorientierungGute MS-Office-KenntnisseKaufmännische Grundausbildung ist von VorteilFremdsprachen (Spanisch, Italienisch) sind von VorteilSie würden sich als aufgeschlossene und kundenorientierte Person beschreiben, die eine Leidenschaft für den Umgang mit Stakeholdern auf verschiedenen Ebenen hat. Sie fühlen sich in einem internationalen Umfeld wohl und möchten auch Ihre Sprachkenntnisse einsetzen. Darüber hinaus sind Sie flexibel in Bezug auf Urlaubs- / Krankheitssubstitutionen. Sie können mit Ihrer sympathischen und freundlichen Art Vifor Pharma vertreten.
Inserat ansehen

26.08.2019

Vifor Pharma

Chemielaborant/in Analytische Entwicklung – St. Gallen

  • Vifor Pharma

  • Switzerland - St Gallen

  • 26.08.2019

  • Vollzeitstelle

In Ihrer Position als Chemielaborant/in Analytische Entwicklung sind Sie verantwortlich für die Entwicklung und Validierung analytischer Methoden, die Qualifizierung analytischer Geräte und die Erhebung von analytischen Daten. In dieser Rolle werden Sie direkt an den Chemiker Analytische Entwicklung berichten. Dabei erfüllen Sie folgende Aufgaben:Entwicklung, Überarbeitung und Validierung analytischer Methoden insbesondere allgemeiner nasschemischer Methoden, chromatographischer Methoden (HPLC, GPC, GC)Durchführung von Routineanalytik (z.B. GPC) im Bereich Forschung und Entwicklung und fallweise Unterstützung der QualitätskontrolleUnterhalt und Betreuung der Geräte als Geräteverantwortliche gemäss aktueller Liste der GeräteverantwortlichenEinführung von neuen Mitarbeitern, welche die von der Stelleninhaberin betreuten Geräte benutzenEinhaltung der GMP-Richtlinien im ArbeitsbereichBefolgung technischer, organisatorischer und personeller SicherheitsmassnahmenFür diese Stelle suchen wir nach einer belastbaren und professionellen Persönlichkeit mit folgendem Profil:Abgeschlossene Lehre als Chemielaborant/in mit analytischem SchwerpunktErfahrung im Bereich der Instrumentellen Analytik Fliessende Deutschkenntnisse in Wort und Schrift, gute Englischkenntnisse Sicherer Umgang mit MS Office Programmen sowie Standard Chemieprogrammen Flexibilität sich rasch auf neue Projekte/Fragestellungen einstellen zu könnenÜbersicht bewahren, wenn an mehreren Projekten gleichzeitig gearbeitet wirdSie sind eine zuverlässige und flexible Persönlichkeit, die gerne im Team arbeitet und Verantwortung für die eigene Arbeit. Zudem verfügen Sie über sehr gute Kommunikationsfähigkeiten schätzen die Teamarbeit.
Inserat ansehen

15.09.2019

Vifor Pharma

Lehrstelle als Laborant/in EFZ Fachrichtung Chemie 2020 - St. Gallen

  • Vifor Pharma

  • Switzerland - St Gallen

  • 15.09.2019

  • Vollzeitstelle

Für diese anspruchsvolle Berufslehre als Laborant EFZ/in suchen wir Sekundarschul-Abgänger oder Personen mit adäquater Ausbildung und starken Leistungen in Mathematik. Während deiner Lehrzeit lernst du folgende Tätigkeiten kennen:Praktische Durchführung wissenschaftlicher UntersuchungenSynthese und Analyse von chemischen SubstanzenBerechnen und Durchführen von chemischen ReaktionenWägen, Messen und Bestimmen von Substanzen, Gasen und FlüssigkeitenErfassen und Interpretieren von DatenDie Berufsschule wirst du in St. Gallen besuchen; die ersten zwei Jahre an zwei Tagen die Woche und im letzten Jahr an einem Tag die Woche. Wenn du die BMS abschliessen möchtest, findet der Unterricht durchgehend zwei Tage die Woche statt.Du besuchst die Sekundarschule oder hast diese bereits abgeschlossen und verfügst über gute schulische Leistungen. Mathematik und naturwissenschaftliche Fächer gehören zu deinen Stärken und du hast Freude an chemischen und technischen Vorgängen. Zudem kannst du dich mit folgendem Profil identifizieren:Logisch-abstraktes Denkvermögen und rasche AuffassungsgabeAusgeprägte Konzentrationsfähigkeit, Geduld und AusdauerFreude am Experimentieren und BeobachtenExakte und systematische ArbeitsweiseGute Team- und KommunikationsfähigkeitSprachen mündlich und schriftlich: Deutsch und EnglischWir wünschen uns eine/n Kandidaten/in welche/r gerne in einem international tätigen Pharmaunternehmen das Laborteam ergänzen möchte. Du bist motiviert Neues zu lernen und kannst dich für technische Herausforderungen begeistern.
Inserat ansehen

20.08.2019

Vifor Pharma

Technical Project Manager - St. Gallen

  • Vifor Pharma

  • Switzerland - St Gallen

  • 20.08.2019

  • Vollzeitstelle

For our Technical Project Management Team, we are currently looking for a Technical Project Manager, based at Vifor (International) AG in St. Gallen. In this function you report directly to the Technical Project Brand Lead within Technical Operations. You will be responsible for managing interdisciplinary projects across all Vifor Pharma organisation. Your responsibilities will include but will not be limited to:Driving and closing of projects according to agreed timelinesEnsuring development and introduction of new/adapted processes/products as according to the objectives and corporate management planningRepresentation of the technical aspects in cross functional committeesFollow and implement state-of-the-art project management standards and tools fit for purposeEngage and maintain appropriate stakeholder management throughout the life cycle of your projectsContact with the external principal/s and selected service providers and contract manufacturing organizationsThe ideal candidate is bringing a degree in natural/life sciences or an associated engineering degree (i.e. Biology, Biochemistry, Chemistry, Pharmaceutics, etc.), in addition to the following experience:Project Management experience with a deep technical understandingExperience in the management of interdisciplinary projects in an international environment, including working with international companies and contractorsExperience in the pharmaceutical or chemical industry, ideally with an understanding of pharmaceutical manufacturing processes, CMC and GMP requirements Strong analytical thinking skillsFluency in English both verbally and in written, German language is an advantageYou are self-motivated Project Manager who brings advanced communication and negotiation capabilities. You describe yourself as a resilient and responsible person with distinctive teamwork skills. Your analytical mindset and your practice-oriented way of working ensure that you always have an overview and a pragmatic solution even in hectic situations. You are a role model for others in terms of the Vifor Pharma Values and continuously display a positive can-do attitude.
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29.08.2019

Vifor Pharma

Stagiaire en planification et ordonnancement de production 100% CDD (h/f) - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 29.08.2019

  • Vollzeitstelle

Nous proposons un stage rémunéré de 6 mois afin de soutenir notre département “Supply Chain Planning” à Fribourg dans ses projets actuels. Nous donnons l'opportunité à un/e étudiant/e fraîchement diplômé/e d’acquérir sa première expérience dans une entreprise pharmaceutique. A ce poste, vous supportez l’équipe de planification de production dans la mise en place de solutions d'améliorations. Vos missions sont les suivantes : Identifier les gaspillages et les pertes de temps afin de proposer des solutions d’améliorationsConcevoir et mettre en place un outil d’aide et de fiabilisation des impressions de documents constituant les dossiers de fabricationCartographier les processus actuels de l’équipe planification de productionPréparer et imprimer les dossiers de production (MBR)Supporter les équipes dans la mise en place d’améliorations Afin de mener à bien ces tâches, nous recherchons une personne proactive et dynamique amenant le profil suivant:Une formation supérieure ( Master et/ou Bachelor ) dans le domaine de la Supply Chain Management ou une formation jugée équivalenteIdéalement, vous bénéficiez d'une première expérience professionnelle dans le domaine de la Supply Chain ManagementNiveau courant en français avec de très bonnes connaissances en anglais, autant à l’oral qu’à l’écritTrès bonnes connaissances des outils informatique office (MS Office) et d’un ERP.Connaissance en base de données SQLDes connaissances des bonnes pratiques de fabricationVous vous décrivez comme une personne rigoureuse et consciencieuse disposant d’un fort esprit d’analyse. Grâce à votre très bonne communication, vous vous intégrez aisément dans une nouvelle équipe. Vous êtes capable d’assurer vos tâches de manière autonome tout en appréciant de collaborer au sein d’une équipe.
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03.09.2019

Vifor Pharma

Pharmaceutical Development Specialist 60% - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 03.09.2019

  • Vollzeitstelle

We are looking for a Pharmaceutical Development Specialist 60% for our production site in Fribourg. At this position, you work within the Pharmaceutical and Analytical Development department and are responsible for the management of pharmaceutical development projects in line with internal Vifor Pharma procedures and according to current international guidelines. Your main activities are:Formulation and packaging development as well as elaboration of suitable manufacturing processes of innovative liquid and solid dosage formsSet-up target product profile and justify product specificationsAuthor and review development, scale-up and manufacturing validation plans and reports, manufacturing instructions, risk analysis and parts of regulatory submissions to support filing.Management of complex manufacturing transfers (out- or back-sourcing)Evaluation of new raw materials or raw material changesSupport for the compilation of technical documentation for the submission of new products or variations to the authoritiesFor this interesting role, we are looking for a dynamic person with the following profile:University Degree (M.Sc., Ph.D.) in pharmacy or similarIdeally 1 to 3 years’ experience in a similar role within the pharmaceutical industryAdvanced theoretical knowledge of pharmaceutical technology for solid and liquid products and knowledge of current GMP standardsFluency in English and French both in oral and written conversation. German is an asset.Mastery of common computer tools such as Ms-OfficeYou describe yourself as a rigorous, conscientious, well-organized and structured person with a strong analytical mindset. Thanks to your good communication skills, you interact easily with other departments. You are able to do your tasks autonomously while enjoying working together as part of a team.
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12.09.2019

Vifor Pharma

Opérateur en Fabrication en Industrie Pharmaceutique 3x8 (h/f) - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 12.09.2019

  • Vollzeitstelle

Au sein du département de production, vos tâches principales consistent à assurer la fabrication des spécialités pharmaceutiques conformes aux spécifications déposées, dans le respect des normes GMP et ISO ainsi que dans les délais impartis. Vos missions sont les suivantes:Conduire les installations de fabricationEffectuer les changements de format, les réglages, les nettoyages, les dépannages et les maintenances de premier niveau sur les équipementsCompléter et signer toute la documentation relative au travail effectuéEtudier et proposer des solutions d’amélioration continueGarantir l’entretien du matériel, des équipements et des zones de productionAfin d’assurer les missions qui vous seront confiées, votre profil est le suivant:Vous possédez 3 ans expérience dans un poste similaire dans le secteur pharmaceutique ou agroalimentaire soumis aux normes BPF et ISOUne formation de CFC de technologue en denrée alimentaire ou une formation jugée équivalente en pharmaceutique ou agroalimentaire est un plusLa maîtrise de la langue française aussi bien à l’oral qu’à l’écrit Vous êtes prêt/e à travailler en 3x8 (du lundi au vendredi).Nous recherchons une personne calme et rigoureuse dotée d’un esprit d’analyse. Capable de comprendre rapidement des processus critiques, vous aimez travailler de façon autonome et assumer des responsabilités. Vous avez un sens de l’observation développé et une grande faculté d’adaptation qui vous permettent de vous intégrer facilement dans une nouvelle équipe.
Inserat ansehen

09.09.2019

Vifor Pharma

Product Manager Women’s Health - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 09.09.2019

  • Vollzeitstelle

At this function, you are in charge of managing a portfolio of products in the Women’s Health Area and are responsible of their sales results on the Swiss Market. As head of the brand team you work closely with our local Medical and Sales Teams as well as with the Global Teams to ensure elaboration and effective implementation of tactical plans. Your contribution to the success of our products is key. Your main responsibilities are the following:Realization of market analysis, competitive analysis and implementation of appropriate measuresDevelopment of marketing strategies and operational implementation of activities related with your portfolio of products “Women’s Health”Elaboration of promotional material and initiation of specific projectsElaboration and management of budgetsOperational support for projects in medical and marketing areasParticipation in national and international congresses and management of KOLsClose collaboration with the Headquarters of Vifor PharmaFor this challenging position, we are looking for a person with an entrepreneurial mindset and strong analytical and conceptual skills. You bring the following profile:University degree in the scientific and/or in business area (such as Economy, Business Administration, Medicine, Pharmacy, Biology or similar)At least 4 years’ experience in pharmaceutical product managementGerman or French as mother tongue with good knowledge of the other language. Very good knowledge of English is also requiredYou describe yourself as an innovative, entrepreneurial, reliable and stress resistant person, who likes to work in interdisciplinary teams. Your excellent and convincing communication skills allow you to successfully interact with your customers both internal and external. Autonomous and objective oriented, you love to embrace new challenges and to use your team spirit to fully contribute to the development of your products’ portfolio “Women’s Health”
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02.09.2019

Vifor Pharma

Laborantin en chimie en contrôle qualité 100% CDD (h/f) - Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 02.09.2019

  • Vollzeitstelle

Afin de renforcer notre équipe contrôle qualité, nous recherchons un laborantin en chimie pour un CDD de 8 mois. A ce poste vous réalisez les analyses physico-chimiques des produits soumis à contrôle afin d’évaluer leur qualité selon les spécifications établies ainsi que participez au maintien du bon état des équipements du laboratoire. Vos missions sont les suivantes :Procéder aux analyses des produits finis et des stabilités GMP et non-GMP selons les instructions internes.Procéder aux qualifications des équipements de serviceParticiper aux développements et aux validations des méthodes analytiquesEffectuer le double contrôle conformément aux procédures, instructions et formulaires en vigueurÉvaluer les résultats d’analysesRédiger la documentation du serviceOrganiser le travail et les activités de façon à respecter les objectifs et délaisAfin de mener à bien les missions qui vous seront confiées, nous recherchons un /e candidat/e proactif/-ve ayant le profil suivant:CFC laborantin en chimie Spécialisation en chimie analytiqueUne première expérience professionnelle à un poste similaireConnaissances sur les pharmacopées européennesMaîtrise des techniques HPLC, CPG, UV, Dissolutest, viscosimètre, CCMConnaissances des normes GMPDe langue maternelle française, des bonnes connaissances en anglais sont un atoutMaîtrise des outils informatiques usuelsVous êtes une personne rigoureuse dotée d'un sens du détail particulièrement développé. Vous appréciez de travailler en équipe et disposez également d'excellentes capacités de rédaction.
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05.09.2019

Vifor Pharma

Head Medical Switzerland – Fribourg

  • Vifor Pharma

  • Switzerland - Villars-sur-Glâne/Fribourg

  • 05.09.2019

  • Vollzeitstelle

In this function, you report directly to the General Manager of Switzerland and lead the Medical Department of approximately 15 people in our Swiss Commercial Affiliate. Your goal is to successfully develop and maintain strong relationships with KOLs and to manage all local medical and scientific activities across therapeutic areas in Switzerland. Your main responsibilities include:Personnel management and resource planningResponsible for Drug Safety, Medical Information, Medical Clearing, Staff training, lIT/observational trials as well as KOL managementProvide leadership and be the key Vifor spokesperson to external and internal bodies on medical scientific issues related to Vifor productsParticipate in management of the local affiliate as member of the Country Management TeamIntegrate affiliate medical perspective into Global TeamsMedical & scientific input into BDL & LCM projectsMedical & scientific support of Marketing Department, including input in marketing plans and conceptsMedical-scientific support for the registration departmentRelease of promotional advertising materialTraining of internal field staff and marketing departmentQuality assurance and quality control within the department Interdisciplinary collaboration for cross-functional assignmentsFor this role, we are looking for a candidate with scientific and medical excellence who demonstrates excellent leadership, communication and presentations skills, bringing the following competencies:Medical Education (MD) or Pharmacy Education (PhD)Minimum 5 years of experience in the pharmaceutical industry in Medical Affairs, and/or Clinical Development at affiliate levelProven experience in direct people management with strong leadershipExperience with clinical study management and conduct as well as with Swiss health care industry compliance regulationsProven relationship building skills with internal and external audiencesGerman or French as mother tongue, with very good knowledge of the second language as well as of English both in written and spoken conversationKnowledge of commercialization and business practices as well as finance and budgeting experienceKnowledge of Drug Safety and PharmacovigilanceYou demonstrate a strong customer orientation and have the ability to continuously expand the market and the scientific knowledge. You are an innovative, determined and assertive person, who likes to work in a very efficient and autonomous way. You like to coach people to achieve performance and feel comfortable in a leader position, where you make decisions and act as an entrepreneur. Furthermore, your negotiation ability, analytical skills and strategic thinking enable you to act as a role model in line with Vifor values.
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