Senior Medical Safety Scientist
Core
Scientific safety expert leading pharmacovigilance, signal detection, and benefit-risk evaluations for assigned products across the product lifecycle.
Role type
Senior Medical Safety Scientist (Pharmacovigilance)
Builds
Safety surveillance plans, signal assessments, aggregate safety reports, and regulatory submissions
Domain
Pharmaceutical industry, Drug Safety & Pharmacovigilance
Required skills
Signal detection and management, Aggregate safety data review, Benefit-risk assessment, Regulatory safety document authoring, Global pharmacovigilance regulations knowledge, Safety signal validation, Pharmacovigilance database management, MedDRA coding, Adverse event analysis
Preferred skills
Experience with Argus Safety, Clinical trial safety monitoring, Post-marketing surveillance
Technologies
Argus Safety, Microsoft Office Suite
Responsibilities
Lead signal detection, validation, and aggregate safety analyses; Author safety narratives, AOSEs, and Safety Surveillance Plans; Support regulatory submissions and health authority responses; Review safety listings and adverse event summaries; Provide scientific expertise to cross-functional governance committees; Ensure compliance with GVP during audits and inspections.
Seniority
Senior, hands-on IC