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
Builds
Safety reports, risk management plans, and regulatory submissions for pharmaceutical clients
Domain
Pharmaceutical industry + Pharmacovigilance
Required skills
Aggregate safety analysis, case-level review, database searching, regulatory document authoring, risk management planning, signal validation, literature review, cross-functional collaboration
Preferred skills
Advanced degree in Health/Biomedical Science, clinical medicine background, clinical/medical writing experience, knowledge of global safety regulations
Technologies
Pharmacovigilance databases, regulatory reporting systems
Responsibilities
Lead Safety Management Team (SMT) meetings and drive decision-making; Author and coordinate core safety deliverables including PBRER/PSUR and DSURs; Conduct database searches and perform aggregate safety analysis; Review regulatory assessor comments and accommodate requests; Lead signal validation and evaluation processes; Provide guidance on Risk Management Plan (RMP) creation and updates; Manage Level 2 escalations and Health Hazard Evaluations (HHE)
Seniority
Senior, hands-on IC