PV Physician-Medical Assessment
Core
Oversight of medical input to benefit-risk assessment activities, including signal detection, evaluation, and risk management plan development.
Role type
Senior Physician (Pharmacovigilance)
Builds
Aggregate safety reports (PSUR, PBRER, DSUR), Risk Management Plans (RMPs), and regulatory responses.
Domain
Healthcare / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical review of individual case safety reports, Signal detection and evaluation, Benefit-risk assessment, Regulatory authority query management, Health Hazard Evaluation preparation, Risk minimization measure design, Clinical study protocol review, Labeling document review, Vendor quality control, SOP development
Preferred skills
Data analysis, Report writing, Problem solving, Decision making
Technologies
PV systems, Safety databases
Responsibilities
Conduct peer quality review of aggregate reports, Validate potential safety signals, Provide medical input to RMPs/REMS, Liaise with Regulatory Affairs for query responses, Review clinical study protocols and final reports, Support product labeling activities, Participate in due diligence for acquisitions
Seniority
Senior, hands-on IC
