Pharmacovigilance Physician
Core
Provides medical oversight of pharmacovigilance activities, including safety signal identification, causality assessment, and periodic safety report generation for pharmaceutical products.
Role type
Senior IC pharmacovigilance physician
Builds
Periodic safety reports (PBRER, PSUR, DSUR), labeling reconciliation documents, CTD modules, REMS, RMP, and Clinical Study Reports (CSR)
Domain
Life sciences / Pharmacovigilance / Drug Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical review of adverse events, causality assessment, MedDRA terminology, regulatory document authoring, safety signal detection, benefit-risk profiling
Preferred skills
Clinical practice experience, academic medicine background, epidemiology, biostatistics, clinical development, medical affairs
Technologies
MedDRA, FDA/ICH/EMA guidelines, GCP, safety databases
Responsibilities
Manage medical aspects of pharmacovigilance tasks across the product life cycle; Provide medical consultation to clients and project teams; Review and analyze serious adverse events and marketed product ICSRs; Identify and investigate safety signals; Contribute to management of benefit-risk profiles; Assist in writing and reviewing safety portions of regulatory submissions
Seniority
Senior, hands-on IC
