Senior Manager, Global Patient Safety - General Medicine
Core
Lead scientific safety strategies for molecules in clinical development and post-marketing phases, including data aggregation, review, analysis, and benefit-risk assessment.
Role type
Senior Manager, Pharmacovigilance
Builds
Safety evaluation reports, regulatory documents (DSUR, PSUR, RMP), and safety presentations for Signal Management Teams
Domain
Pharmaceutical/Biotech, General Medicine
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
pharmacovigilance strategy, signal detection and evaluation, regulatory document preparation, safety data analysis, guideline application (FDA/EU/ICH), cross-functional collaboration
Preferred skills
process improvement, SOP/WI development, external committee representation
Technologies
safety system databases
Responsibilities
Complete signal detection activities per safety surveillance plans, author safety evaluation reports, manage preparation and review of regulatory safety documents, deliver presentations at Signal Management Team meetings, participate in risk management activities, represent the team on cross-functional committees, lead process improvement initiatives
Seniority
Senior Manager, hands-on IC with strategic oversight
