About the Role
Senior Safety Scientist to provide scientific leadership across drug safety and pharmacovigilance programs. This role involves strategic oversight of signal detection, aggregate reporting, and benefit-risk management, supporting global regulatory submissions and safety governance.
Key Responsibilities
Lead signal management strategy and safety governance meetings
Provide expert oversight for literature review and signal evaluation
Author, review, and approve aggregate safety reports (PSUR/PBRER, DSUR, RMP)
Drive benefit-risk assessments and risk minimization strategies
Interface with Regulatory Authorities, Medical Affairs, and Global Safety teams
Support inspections, audits, and responses to health authority queries
Mentor and guide mid-level and junior safety scientists
Contribute to process improvement, SOP development, and PV strategy
Requirements
Advanced degree in Pharmacy, Medicine, Life Sciences, or equivalent
10+ years of progressive experience in Drug Safety / Pharmacovigilance
Deep expertise in signal detection, aggregate reporting, and global PV regulations
Strong leadership, decision-making, and strategic communication skills
Experience working with global sponsors, CROs, or regulatory agencies