Temp Mgr Global Patient Safety Sciences
Core
Manage global patient safety strategies for molecules in clinical development and post-marketing phases, including safety data aggregation, review, analysis, and benefit-risk assessment.
Role type
Senior individual contributor clinical safety manager
Builds
Safety evaluation reports, regulatory documents (DSUR, PSUR, RMP), and presentations for Signal Management Teams
Domain
Pharmaceutical industry, clinical safety, pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
signal detection, signal evaluation, safety document preparation, regulatory query response, risk management, data manipulation and visualization, SOP development
Preferred skills
therapeutic area expertise, health authority experience
Responsibilities
Complete signal detection activities per safety surveillance plans; perform signal evaluation and author safety reports; manage preparation and review of safety documents; deliver presentations at Signal Management Team meetings; participate in cross-functional safety oversight committees; engage in process improvement initiatives
Seniority
Manager, hands-on IC
