Associate Director, Global Patient Safety - Ophthalmology
Core
Lead global patient safety strategies for molecules in clinical development and post-marketing phases, including data aggregation, signal detection, evaluation, and benefit-risk assessments.
Role type
Senior individual contributor pharmacovigilance director
Builds
Safety evaluation reports, regulatory documents (DSUR, PSUR, RMP), and safety strategies
Domain
Pharmaceutical/Biotech, Pharmacovigilance
Required skills
Pharmacovigilance, Signal detection, Benefit-risk assessment, Regulatory guidelines (FDA/EU/ICH), Safety data analysis, SOP development
Preferred skills
Ophthalmology therapeutic area, Health authority experience
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 Signal Management Team meetings, Participate in cross-functional teams and committees, Provide medical review resources for assigned compounds, Participate in process improvement initiatives
Seniority
Senior, hands-on IC