Senior Scientist, Risk Management & Safety Surveillance
Core
Senior scientist responsible for aggregate safety reports, case-level reviews, and safety strategy development for pharmaceutical products.
Role type
Senior IC pharmacovigilance scientist (risk management & safety surveillance)
Builds
Periodic safety reports (PBRER/PSUR/DSUR), Risk Management Plans, and aggregate safety analyses
Domain
Pharmaceutical industry + Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
aggregate safety analysis, case-level review, database searching, safety report authoring, risk management plan guidance, signal validation, regulatory query response, clinical data evaluation
Preferred skills
clinical writing, drug development principles, global safety regulations knowledge, therapeutic area expertise
Technologies
Pharmacovigilance databases, safety reporting systems
Responsibilities
Lead Safety Management Team (SMT) meetings and drive decision-making; Review and align approvals for Periodic Benefit Risk Evaluation Reports (PBRER) and Periodic Safety Update Reports (PSUR); Conduct database searches and perform aggregate safety analysis; Evaluate clinical data for adverse drug reactions and characterize risks; Lead signal validation and evaluation processes; Respond to health authority queries and prepare Marketing Authorization Holder (MAH) comments; Update label information and Clinical Overviews with safety sections; Manage Level 2 escalations and Health Hazard Evaluations (HHE)
Seniority
Senior, hands-on IC
