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Cette offre a expire le 17/09/2026. Elle n'accepte plus de candidatures.
Drug Safety and Pharmacovigilance Manager
Aspeya · Lausanne
Description du poste
About the role
As a Drug Safety and Pharmacovigilance Manager at Aspeya, you will lead the collection, assessment, documentation, and communication of safety information for a diverse portfolio that includes medical cannabis, natural health products, and clinical development programs. This hands‑on position requires a seasoned PV professional who can ensure high‑quality safety data throughout the product lifecycle.
Key responsibilities
- Manage adverse event case processing, from intake and triage to assessment, follow‑up, documentation, quality review, and regulatory reporting.
- Maintain complete, accurate, traceable, and inspection‑ready safety data in safety databases, trackers, and PV systems.
- Prepare and review safety documents such as case narratives, aggregate reports, annual summaries, regulatory responses, and risk assessments.
- Monitor and evaluate the safety profile of assigned products, including medical cannabis and consumer wellness items.
- Act as Safety Lead on projects, analysing safety data, identifying trends, and providing risk recommendations.
- Conduct post‑marketing surveillance activities, including signal detection, safety review, and risk management.
- Collaborate with clinical development, regulatory affairs, and cross‑functional teams to embed pharmacovigilance into business processes.
Required profile
- Experienced pharmacovigilance professional with a proven track record in case processing and safety data management.
- Strong understanding of global PV regulations across multiple product types.
- Excellent safety writing and communication skills.
- Ability to lead safety activities across clinical development and post‑marketing phases.
Required skills
What we offer
- Opportunity to shape pharmacovigilance strategy in a dynamic, innovative company.
- Collaborative environment with a highly experienced team.
- Broad scope of responsibilities across a growing product portfolio.
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Aspeya
Lausanne
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