Drug Safety Physician

1w1 week ago

Idorsia

Allschwil, CH · Full-time · CHF 190,000 – CHF 240,000

About this role

Headquartered near Basel, Switzerland, Idorsia seeks a curious and talented physician eager to expand expertise in drug safety. This role offers a unique opportunity to deepen knowledge in pharmacovigilance while contributing to patient safety. It suits skilled profiles in a dynamic, collaborative environment.

Accountable for safety aspects of assigned marketed products, lead the cross-functional Safety Management Team for integration and analysis of safety data. Perform signal detection, monitoring, evaluation, and management of safety information across the product lifecycle. Prepare periodic safety reports like DSUR and PSUR/PBRER.

Coordinate presentations at the Idorsia Drug Safety Committee with accurate safety profile reviews. Conduct medical reviews of adverse event reports for coding, seriousness, and causality assessments. Respond to safety inquiries from regulatory authorities and support inspections.

Enjoy a collaborative culture that encourages teamwork, initiative, and new ideas. Gain international exposure in a multicultural setting with global colleagues. Benefit from development opportunities to grow and expand expertise in a dynamic organization.

Requirements

Doctor of Medicine degree with at least 5 years’ experience in global drug safety in the pharmaceutical or biotechnology industry
Full understanding of post-marketing adverse experience reporting systems and experience in product safety monitoring
Experience in preparation of post-marketing regulatory safety reports/documents
Excellent medical writing and presentation skills
Excellent interpersonal, communication and negotiation skills
Excellent organizational and planning capabilities and ability to meet timelines

Responsibilities

Accountable for all aspects of safety related primarily to assigned marketed products
Act as responsible Drug Safety Physician assigned to projects in early development
Lead the cross-functional Safety Management Team for assigned products
Coordinate presentations at Idorsia Drug Safety Committee on product safety profiles
Responsible for overall signal detection, monitoring, evaluation and management of safety information
Prepare aggregated periodic safety reports including DSUR, PSUR/PBRER and RSI sections
Perform medical review of adverse event reports for proper assessment and follow-up
Respond to safety inquiries from regulatory authorities and support inspections

Benefits

Development opportunities to grow, learn, and expand expertise in a dynamic and international organization
Collaborative culture with a supportive, solution-oriented environment where teamwork, initiative, and new ideas are encouraged
International exposure in a truly multicultural setting with colleagues and partners from around the world