Medical Director, Drug Safety & Pharmacovigilance

Senior Medical Director, Drug Safety & Pharmacovigilance

The Senior Medical Director (Sr. MD) will serve as a Product Safety Lead for clinical development programs and/or post-marketing products. Reporting to the VP of Drug Safety and Pharmacovigilance, this role involves leading medical assessment and interpretation of safety data from clinical trials, post-marketing reports, aggregate reports, and literature. The Sr. MD will collaborate cross-functionally to support clinical programs, regulatory filings, and global safety activities.

Key Responsibilities:

• Provide medical safety leadership in clinical studies, including strategic safety monitoring and signal detection.
• Collaborate with Clinical and other teams on trial protocols, informed consent forms, investigator brochures, and safety information.
• Contribute to aggregate safety reports, study reports, and risk management plans.
• Support development and updates of standard operating procedures and safety guidance documents.
• Act as a subject matter expert for pharmacovigilance vendors.
• Address safety-related inquiries from regulatory authorities and participate in inspections.
• Provide mentorship as needed.

Qualifications:

• MD degree from a recognized medical school.
• 6+ years of experience as a Medical Safety Lead/Global Safety Officer in clinical trials.
• Strong knowledge of drug safety regulations (US/EU), safety surveillance, and risk management.
• Experience in medical safety assessments, ICSRs, aggregate report preparation, and regulatory interactions.
• Excellent communication and collaboration skills.