Director, Patient Safety (MD)
Core
Provide medical leadership and oversight of individual case safety report review activities across marketed and investigational products to support patient safety and regulatory compliance.
Role type
Director, Patient Safety Medical Review Physician
Builds
Medical safety assessments, peer retrospective quality control, and regulatory compliance for pharmaceutical products
Domain
Pharmaceutical industry + Pharmacovigilance
Required skills
Clinical judgment, Medical review expertise, Regulatory knowledge, Strategic guidance, Process improvement, Mentorship
Preferred skills
Board certification, Residency program completion, Global regulatory knowledge
Technologies
None stated
Responsibilities
Perform peer retrospective medical review quality control activities, Respond to medical review-related questions from other functions, Collaborate with global safety leads on SUSAR reports, Provide medical consultation to functional groups, Develop and refine medical review processes, Support internal and external audit and inspection, Provide mentorship and training to junior staff
Seniority
Director, strategic leadership with hands-on expert contribution