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Senior Pharmacovigilance Manager (m/f/d) - Local Safety Officer and QPPV CH & LI - 100%

Date: Aug 24, 2021

Location: Basel, CH, 4010

Company: Teva Pharmaceuticals

Mepha Schweiz

Mepha Schweiz Ltd. is currently looking for a Local Safety Officer and Qualified Person for Pharmacovigilance. In this role you will be responsible for the local pharmacovigilance system in close collaboration with the regional and global pharmacovigilance organization of Teva Pharmaceuticals. You will lead a small team with internal and external personnel. We are looking for someone with profound experience of Swiss regulations and the interest and motivation to renew the local organization and processes.

Your tasks

• Overseeing and conducting the routine pharmacovigilance tasks in an affiliate

  • Case processing (collection, global database entry, QC, follow-up and submission)
  • Collaborating with Regulatory Affairs on submission of PSURs and RMPs and implementation of CCSI
  • Developing pharmacovigilance activities and risk minimization activities for Mepha’s products, agreeing them with Swissmedic and ensuring their implementation
  • Responsible for developing and maintaining local pharmacovigilance agreements
  • Coordination of Health Hazard Assessments
  • Reconciliation activities
  • CAPA management

• Responsible for pharmacovigilance compliance with Swiss regulations and local SOPs, also for external contractual partners, including training and SOP maintenance
• Main contact for Swissmedic on all pharmacovigilance matters
• 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

Your profile

• Master degree in life sciences, pharmacist, or health science professional degree
• Minimum 7 years’ experience in Swiss pharmacovigilance, mainly in 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 French and/or Italian is a strong plus
• Leadership experience is preferred
• A confident handling of Microsoft Office Tools (Excel, Word, PowerPoint) is required
• You are detail oriented showing a high level of responsibility and accuracy
• You are a team player with strong communication skills and you are at ease when working in a dynamic environment

Our offer

• We offer a demanding job opportunity with a high degree of personal responsibility to shape the local pharmacovigilance team and processes
• A professional, and pleasant environment awaits you at the market-leading company in the field of generics
• We value and welcome motivated personalities with sound professional competence

Function

Regulatory Affairs

Reports To

Dir European Pharmacovigilance

Contact

Dr. Katrin Kemmer

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Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.