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Senior Manager (m / f / d) Pharmacovigilance 100%
Teva PharmaceuticalsBasel, SwitzerlandVor 16 Tagen
StellenbeschreibungOverseeing and conducting the routine pharmacovigilance tasks in the Swiss affiliate in collaboration with regional & global PV : Case processing (collection, global database entry, QC, follow-up and submission) Collaboration with Regulatory Affairs on submission of PSURs and RMPs and implementation of CCSI and signal management Development of pharmacovigilance activities and risk minimization activities for Teva and Mepha’s products, agreeing them with Swissmedic and ensuring their implementation Responsibility for developing and maintaining local pharmacovigilance agreements Coordination of Health Hazard Assessments Reconciliation activities CAPA management Responsible for pharmacovigilance compliance with Swiss regulations and company SOPs, also for external contractual partners, including and SOP maintenance and training Main contact for Swissmedic on all pharmacovigilance matters Lead for specific PV DACH topics : Act as subject matter expert and execute key activities for all DACH countries in close collaboration with LSOs (e.g. license contracts, due diligence), Ensure regulatory compliance, in conjunction with Teva Global, European PV and local Teva management. Act as back-up for LSO-Austria and LSO-Germany Be part of a team of PV cluster topic leads DACH Ensuring good working relationships with all interfacing units / external contractual parties Representing drug safety and providing relevant inputs in local projects and activities Leading the Local Pharmacovigilance team, including budget responsibility Participation in association work Master degree in life sciences, pharmacist, or health science professional degree Minimum 5 years’ experience in Pharmacovigilance, mainly in Swiss pharmaceutical industry Profound knowledge and understanding of Swiss regulations with regard to pharmacovigilance practices for medicinal products and medical devices. Very good knowledge of ICH (GCP) and EU Good Pharmacovigilance Practice (GVP) Good level of medical knowledge Fluency in English and German is a must, language skills in Italian and / or French is a strong plus Leadership experience is preferred A confident handling of Microsoft Office Tools (Excel, Word, PowerPoint) is required You combine a high level of responsibility, flexibility and accuracy with the ability to work in a fast moving, multitask environment You are a team player with strong communication skills, and you are at ease working in a matrix organisation Opportunity to engage in an interesting, varied, and exciting role within a dynamic team in a growing organization with an international scope Enjoy versatile and challenging work that provides valuable insights into various business processes Benefit from progressive perks such as a lunch card and public transport allowance Work at our central office, just a few minutes' walk from Basel SBB train station, ensuring easy commutes
About Mepha and Teva in Switzerland
Mepha Pharma AG and Teva Pharma AG are together among the leading pharmaceutical companies in Switzerland. Since 2011, Mepha is part of the internationally active Teva Group, one of the world's leading suppliers of generics. Mepha and Teva are based in Basel and currently employ 174 people in total. The portfolio of Mepha and Teva comprises over 320 products, which are primarily used in primary care to treat a wide range of diseases. The range includes about 270 generics, over-the-counter medicines, dietary supplements, medical products, biosimilars, biologicals and other original medicines. The latter are used to treat diseases of the central nervous system, the respiratory tract and cancer. Mepha and Teva distribute their products via pharmacies, self-dispensing doctors, wholesalers and hospitals. With around 23 million
- packs, Mepha and Teva sold the most medicines in Switzerland in 2023.
Who are we looking for
Senior Manager (m / f / d) Pharmacovigilance (Local Safety Officer & QPPV for Switzerland and Liechtenstein) and PV Cluster Topic Lead DACH
Main Responsibilities
Your experience and qualifications
What we offer
Function
Research & Development