Drug Safety Physician

About the role

Idorsia is seeking an experienced Drug Safety Physician to lead safety activities for assigned products across development and post‑marketing phases. This senior medical safety leader will influence cross‑functional teams and engage with global health authorities.

Key responsibilities

• Lead the Safety Management Team for assigned products, integrating and interpreting safety information from preclinical through the product life‑cycle.
• Oversee signal detection, monitoring, evaluation and management of safety data, and prepare aggregated periodic safety reports (DSUR, PSUR/PBRER) and other regulatory documents.
• Conduct medical review of adverse event reports, ensure proper coding, seriousness, expectedness and causality assessment, and respond to regulatory safety inquiries.
• Present safety profiles and recommendations to the Idorsia Drug Safety Committee and support regulatory authority inspections.

Required profile

• Medical degree (MD) with substantial experience in global drug safety within the pharmaceutical or biotechnology industry.
• Deep understanding of post‑marketing adverse experience reporting systems and product safety monitoring.
• Excellent medical writing, presentation, interpersonal and negotiation skills.
• Strong organizational abilities with a proven track record of meeting timelines.

Required skills

• Pharmacovigilance expertise
• Signal detection and benefit‑risk assessment
• Regulatory safety reporting (DSUR, PSUR, PBRER, RMP)

What we offer

• Strategic impact on product safety strategy across development and commercialized products.
• Scientific leadership collaborating with internal and external experts on complex safety challenges.
• Global, highly international work environment with broad cross‑functional exposure.