Senior Physician, Patient Safety
Core
Provide medical expertise and oversight across pharmacovigilance and patient safety activities for investigational and marketed products.
Role type
Senior IC physician (pharmacovigilance)
Builds
Safety reports, regulatory submissions, and risk management plans
Domain
Life sciences / Pharmacovigilance
Required skills
Medical review, signal detection, safety surveillance, causality assessment, regulatory compliance (GCP/GVP), aggregate reporting, risk management, literature review, mentorship
Preferred skills
ICSR medical review experience, aggregate safety report preparation, risk management planning, training/mentoring, global regulatory environment experience
Technologies
Safety databases, web-based applications, Windows operating systems
Responsibilities
Review and author individual case safety reports (ICSRs), conduct signal detection and management, prepare aggregate safety reports (PSURs, PBRERs), provide medical guidance to safety associates, support regulatory submissions, maintain product safety profiles, collaborate on inspection readiness
Seniority
Senior, hands-on IC