Medical Safety Dir
Core
Provide global medical expertise and oversight for pharmacovigilance services, including adverse event review, regulatory reporting, and safety profile management across clinical trials and post-marketing projects.
Role type
Senior medical safety director (pharmacovigilance)
Builds
Regulatory safety reports, risk management plans, and integrated safety summaries for life sciences clients
Domain
Life sciences / Pharmacovigilance / Clinical Research
Required skills
Medical degree, clinical practice experience, regulatory knowledge, clinical trial process expertise, medical review and coding, project leadership, bid defense
Preferred skills
Valid medical license, global safety physician experience
Technologies
None stated
Responsibilities
Review and clarify trial-related adverse events and post-marketing reactions; compose and review Analyses of Similar Events; provide aggregate reviews of safety information; review regulatory reports (IND Annual Reports, PSURs, etc.); oversee label development; attend Data Safety Monitoring Board meetings; lead global medical safety projects; provide 24-hour medical support; participate in RFP reviews and bid defenses.
Seniority
Senior, hands-on IC with leadership responsibilities