Principal Safety Scientist - SERM
Core
Provides medical/scientific knowledge in the safety evaluation and risk management of GSK products in clinical development and/or the post-marketing setting.
Role type
Principal Safety Scientist (Pharmacovigilance)
Builds
Global periodic safety reports, aggregate reports, Risk Management Plans (RMPs), and safety documentation for assigned portfolio.
Domain
Pharmaceutical/Biotech, Pharmacovigilance, Clinical Safety
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Signal detection, Adverse event reporting, Safety evaluation methods, Clinical development safety, Post-marketing safety activities, Medical terminology, Study design
Preferred skills
Regulatory safety documents, Risk management plans, Global safety requirements, Pharmacovigilance regulations, Safety signal detection tools
Technologies
Safety databases, Safety signal detection tools
Responsibilities
Leads signal detection and evaluation activities for assigned products; Produces clear, accurate, and fit-for-purpose safety evaluations; Contributes to Risk Management Plans (RMPs) and risk assessments; Authors and reviews global periodic safety reports and regulatory documents; Participates in process improvement initiatives and audit follow-up; Supports Safety Review Teams (SRTs) and governance activities; Implements risk minimization strategies in clinical protocols and product labeling.
Seniority
Principal, hands-on IC with potential for team leadership
