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Drug Safety Physician

Idorsia Pharmaceuticals Ltd · Bâle et périphérie

🇬🇧 English

Job description

About the role

Idorsia, a Swiss biotech listed on the SIX Swiss Exchange, is seeking a Drug Safety Physician to join its pharmacovigilance team. The role offers the chance to deepen expertise in drug safety while contributing to patient protection across the product life‑cycle.

Key responsibilities

  • Take accountability for safety activities related to assigned marketed products.
  • Lead the cross‑functional Safety Management Team (SMT) and present safety assessments to the Idorsia Drug Safety Committee.
  • Conduct signal detection, monitoring, evaluation and management of safety information throughout the product life‑cycle.
  • Prepare aggregated periodic safety reports (DSUR, PSUR/PBRER) and sections such as Reference Safety Information for Investigator Brochures.
  • Perform medical review of adverse event reports, ensuring proper coding, seriousness, expectedness and causality assessment.
  • Respond to safety inquiries from regulatory authorities and support health‑authority inspections.

Required profile

  • Medical degree (MD) with at least five years of global drug safety experience in the pharmaceutical or biotechnology industry.
  • Comprehensive understanding of post‑marketing adverse experience reporting systems and regulatory safety reporting.
  • Excellent medical writing, presentation, interpersonal and negotiation abilities.
  • Strong organizational and planning skills with the capacity to meet tight timelines.

Required skills

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    Published 4 months ago

    28 views · 0 interested

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    Idorsia Pharmaceuticals Ltd

    Bâle et périphérie