Senior Manager, Global Patient Safety Sciences - Oncology
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 strategies
Domain
Pharmaceutical/Biotech, Oncology
Required skills
Pharmacovigilance expertise, Signal detection and evaluation, Regulatory guideline application (FDA, EU, ICH), Safety database management, Risk management, SOP/WI development
Preferred skills
Cross-functional team representation, Process improvement initiatives
Technologies
Safety system databases
Responsibilities
Complete signal detection activities, Perform signal evaluation and author safety reports, Manage preparation and review of safety documents, Prepare and deliver presentations at SMT meetings, Participate in risk management activities, Represent team on cross-functional committees, Participate in process improvement initiatives
Seniority
Senior Manager, hands-on leadership