Senior Physician, Patient Safety
Core
Senior medical expert performing complex case reviews, causality assessment, and regulatory compliance for adverse event reporting in clinical trials.
Role type
Senior IC pharmacovigilance physician (medical review)
Builds
Production safety data and regulatory-compliant case narratives for drug sponsors
Domain
Healthcare / Pharmacovigilance / Clinical Trials
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Medical terminology, ICSR medical review, pharmacovigilance, drug safety, clinical practice, global regulatory requirements, adverse event reporting, MedDRA coding, causality assessment, narrative coherence review, follow-up query management
Preferred skills
Subject matter expertise, audit/inspection support, process improvement, mentoring, bid defense participation
Technologies
MedDRA, Standard Operating Procedures (SOPs)
Responsibilities
Perform medical review of complex clinical trial and combination product cases; Assess seriousness, listedness, and expectedness of reported adverse events; Write Pharmacovigilance/MAH comments and assess company causality; Review and verify selection of adverse events from source documents; Coordinate with clients to resolve case issues; Mentor Patient Safety Physicians
Seniority
Senior, hands-on IC
