Medical Director M-SERM
Core
Lead medical safety evaluation and risk management efforts, including reviewing adverse events, managing signal detection, and ensuring accurate medical content in regulatory reports.
Role type
Senior Medical Director (Pharmacovigilance)
Builds
Safety reports, regulatory submissions, and risk management plans for clinical trials and marketed products.
Domain
Life Sciences / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical review of adverse events, signal detection, regulatory report writing, safety data analysis, mentorship of entry-level staff
Preferred skills
Therapeutic expertise in specific medical specialties, active medical license
Technologies
MedDRA, ARGUS, ARISg
Responsibilities
Medically review adverse events and serious adverse event data, manage signal detection activities, review and write safety reports (CSR, IND/NDA, ICSR, RMP, REMS), provide medical consultation to team members, train staff on safety reporting
Seniority
Senior, hands-on IC
