Switzerland Job Openings
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Teva Pharmaceuticals
Senior Manager (m/f/d) Pharmacovigilance 100%
Basel
FULL TIME
November 4, 2024
- Overseeing 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, Power Point) 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
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