Drug Safety Physician mwd

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 postmarketing 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 postmarketing 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.
• Youre skilled in safety signal identification and implementing risk minimization strategies.
• Your exceptional medical writing and presentation abilities facilitate clear communication within crossfunctional 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.