Local Safety Officer (m/f/d) and QP for Pharmacovigilance Switzerland and Liechtenstein – 100%
Job title: Local Safety Officer (m/f/d) and QP for Pharmacovigilance Switzerland and Liechtenstein – 100%
Company: Teva Pharmaceuticals
Job description: About Mepha Schweiz
Mepha Schweiz Ltd. is one of the leading pharmaceutical companies in Switzerland and since 2011 part of the Teva Group, the global number one in the generics market. Mepha Schweiz, based in Basel, includes Teva Pharma Ltd and Mepha Pharma Ltd, which holds the number one position in the Swiss generics market. The company currently employs 157 people. The sales company Mepha Pharma Ltd markets over 230 branded and non-branded generics. The Mepha portfolio covers 17 medical indication areas. The medecines are sold to pharmacies, through self-dispensing doctors, drugstores and hospitals. The sales company Teva Pharma Ltd offers over 60 specialties in Switzerland in the fields of central nervous system, cancer and respiratory diseases.
Mepha Schweiz Ltd. is currently looking for a Senior Pharmacovgilance Manager in the function of 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 of one internal Pharmacovigilance Associate, and external personnel. We are looking for someone with profound pharmacovigilance experience and the interest and motivation to renew the local organization and processes.
- 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 a small local Pharmacovigilance team, including budget responsibility
- You have a Master’s degree in life sciences/pharmaceutical sciences, or you are having a health science professional degree
- Minimum of 7 years’ experience in pharmacovigilance, mainly in the pharmaceutical industry
- Very good knowledge of ICH and EU Good Pharmacovigilance Practice (GVP)
- Knowledge and understanding of Swiss regulations with regard to pharmacovigilance practices for medicinal products and medical devices would be a strong advantage
- Good level of medical knowledge
- Fluency in English and German is a must, language skills in French and/or Italian is a strong plus
- 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
- 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
Dir European Pharmacovigilance
Dr. Katrin Kemmer
Pre-employment background screening
Mepha Schweiz Ltd will carry out appropriate verification and legally permitted vetting prior to the confirmation of any offer of employment. More information on this verification and vetting will be provided if you reach this stage of the application process.
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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.
Location: Basel – Liechtenstein
Job date: Wed, 28 Jul 2021 07:57:01 GMT
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