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Drug Safety Physician
Idorsia Pharmaceuticals Ltd · Bâle et périphérie
Description du poste
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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Idorsia Pharmaceuticals Ltd
Bâle et périphérie
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