Drug Safety Physician
vor 3 Wochen
We have an exciting opportunity for a Drug Safety Physician (m/w/d) in Switzerland
Tasks
- You are responsible for safety aspects of marketed products, including reviewing post-marketing AE reports, signal detection, risk management, and risk minimization.
- Lead the Safety Management Team, ensuring integration and interpretation of safety information.
- Coordinate and ensure quality presentations by the SMT at Drug Safety Committee (DSC).
- Participate in Clinical Project and Life Cycle Team meetings.
- Responsible for overall signal detection, monitoring, and preparation of safety reports (DSUR, PSUR/PBRER).
- Contributes to key regulatory safety documents including RSI in the IB and RMP/REMS.
- Review and triage AE reports, ensuring proper assessment and documentation.
- Handle safety inquiries from regulatory authorities and healthcare professionals.
- Coordinate involvement of external experts and support licensing agreements.
- Assist in managing regulatory inspections and collaborate with Quality Management on product complaints associated with AE.
**Requirements**:
- You hold a Doctor of Medicine degree with at least 5 years of experience in global drug safety in the pharmaceutical or biotechnology industry.
- Your knowledge spans medicinal products, diseases, safety surveillance, and pharmacovigilance, derived from both didactic and clinical backgrounds.
- You excel in post-marketing adverse event reporting systems, product safety monitoring, and the preparation of regulatory safety documents.
- Proficient in global safety regulations, GCP, GVP, and pharmacovigilance compliance, you ensure adherence to industry standards.
- Your familiarity with key safety documents like DSUR, PBRER, RMP, and CCDS enhances your effectiveness in safety management.
- You're skilled in safety signal identification and implementing risk minimization strategies.
- Your exceptional medical writing and presentation abilities facilitate clear communication within cross-functional teams.
- Your organizational prowess ensures timely project delivery, supported by your experience with the Argus Safety database.
Thank you for considering this opportunity. I look forward to connecting with you.
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