Physician, Post-Marketing Research
Core
Medical oversight of pharmacovigilance activities to ensure regulatory compliance and manage safety signals for marketed products and clinical trials.
Role type
Senior IC clinical physician (pharmacovigilance)
Builds
Periodic safety reports (PBRER, PSUR, DSUR), labeling reconciliation documents, CTD modules, REMS, RMP, and CSR safety sections
Domain
Life sciences / Pharmacovigilance / Drug Safety
Required skills
Medical review of adverse events, causality assessment, MedDRA terminology, periodic safety report generation, regulatory guideline interpretation (FDA/ICH/EMA/GCP), signal detection, therapeutic knowledge
Preferred skills
Clinical trial experience, Contract Research Organization experience, Principal Investigator experience, safety/pharmacovigilance direct experience
Technologies
MedDRA, safety databases, biostatistics tools, clinical operations software
Responsibilities
Manage medical aspects of contracted pharmacovigilance tasks across the pharmaceutical product life cycle, Provide medical review and analysis for clinical trial serious adverse events and marketed products ICSR, Identify and investigate safety signals and contribute to the management of the benefit-risk profile, Assist in writing and reviewing the safety portion of CSR, IND/NDA report, ICSR, signal detection reports, and periodic reports, Provide medical consultation to team members and clients, Perform data reviews and validation of adverse event data from all sources
Seniority
Senior, hands-on IC