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Drug Safety and Pharmacovigilance Manager

Aspeya · Lausanne

Senior 🇬🇧 English

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.

    Questions fréquentes

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    Aspeya

    Lausanne