Senior Associate Global Safety (Local Safety Switzerland)
amgen · Rotkreuz
Description du poste
About the role
Support local pharmacovigilance activities in Switzerland and provide safety expertise to the business, ensuring compliance with Swiss legislation and Amgen policies.
Key responsibilities
- Maintain compliance with Swiss safety regulations and update SOPs, manuals and reporting requirements.
- Handle adverse event information, local literature reviews, safety reporting obligations and urgent safety communications.
- Support inspection readiness, inspections and internal audits.
- Collaborate with Commercial, Medical, Regulatory, Quality, Legal and Market Access teams to embed PV requirements.
- Review local programs, vendor contracts, websites/social media projects, patient support programs and market research from a PV perspective.
Required profile
- University degree in life sciences, pharmacy, medicine or related field.
- Experience in pharmacovigilance, preferably in a pharmaceutical or biotech affiliate.
- Practical understanding of Swiss PV requirements for post‑marketing and clinical trials.
- Strong organizational, stakeholder management and problem‑solving skills.
- Fluent in English and German; French or Italian a plus.
Required skills
- Pharmacovigilance
- Adverse event reporting
- Swiss PV regulatory knowledge
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