Pharmacovigilance Associate
vor 4 Wochen
About Mepha and Teva in Switzerland
Mepha Pharma AG and Teva Pharma AG are two of the leading pharmaceutical companies in Switzerland. They have a strong presence in the country, employing over 174 people in Basel. The companies have a diverse portfolio of over 320 products, covering various therapeutic areas. Their products are primarily used in primary care, and they have a significant presence in the generics market, with over 270 products available. In addition to generics, their portfolio includes over-the-counter medicines, dietary supplements, medical products, biosimilars, and original medicines. The latter are used to treat diseases of the central nervous system, respiratory tract, and cancer. Mepha and Teva distribute their products through a variety of channels, including pharmacies, self-dispensing doctors, wholesalers, and hospitals.
Job Summary
Mepha Schweiz Ltd is seeking a Pharmacovigilance Associate to support the Head of Pharmacovigilance Switzerland and Local Safety Officer in maintaining the local Pharmacovigilance System. The successful candidate will work closely with the PV cluster, regional, and global Pharmacovigilance Organization of Teva Pharmaceuticals. Key responsibilities include managing the collection and processing of Adverse Events/Special Situations, conducting reconciliation of safety data, and supporting authority requests and signal screening activities.
Key Responsibilities
- Manage the collection and processing of Adverse Events/Special Situations in compliance with local and regional regulations and company SOPs
- Conduct reconciliation of safety data with other departments and partners
- Support authority requests, signal screening, and signal reporting activities
- Support management of local SOPs and procedures, including writing documents
- Organize and deliver PV trainings to other departments and stakeholders
- Support planning submission and tracking of Periodic Safety Update Reports (PSUR), Development Safety Update Reports (DSUR), Risk Management Plans, and Company Core Safety Information (CCSI) activities
- Support development, updates, and tracking of additional Risk Minimization Measures (aRMM) and PV agreements
- Coordinate Health Hazard Assessments
- Represent drug safety and provide input in local projects
- CAPA management
- Contribute to PSMF compliance
Requirements
- Degree in a life science related field (medical, pharmaceutical, nursing, or natural science background)
- Minimum 2 years of experience in Pharmacovigilance
- Good knowledge of Swiss regulations and ICH/GCP
- Basic level of medical knowledge
- Confident handling of Microsoft Office Tools (Excel, Word, PowerPoint)
- Fluent in German and English, additional languages an advantage
- Analytical thinking, reliability, and team-oriented
What We Offer
- Interesting and challenging position in a team environment
- Market-based compensation package
- Responsible position with business impact
- Attractive employment conditions
Function
Research & Development
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