Manager, Global Patient Safety Scientist
Core
Lead safety strategies for molecules in clinical development and post-marketing phases, including data aggregation, review, analysis, and benefit-risk assessment.
Role type
Manager, Global Patient Safety Scientist
Builds
Safety evaluation reports, regulatory documents (DSUR, PSUR, RMP), and safety surveillance plans
Domain
Pharmaceutical / Pharmacovigilance
Required skills
Safety data aggregation and analysis, Signal detection and evaluation, Regulatory guideline application (FDA, EU, ICH), Safety document preparation, Process improvement (SOPs/WIs), Data manipulation and visualization
Preferred skills
Therapeutic area expertise, Safety system database experience
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 cross-functional teams and committees, Lead process improvement initiatives
Seniority
Manager, hands-on IC