About the Role
Looking for an experienced Mid-Level Safety Scientist to independently manage drug safety activities across multiple products and therapeutic areas. This role requires hands-on expertise in signal detection, literature review, and aggregate reporting, with the ability to mentor junior team members.
Key Responsibilities
Conduct and oversee literature surveillance and evaluation
Lead signal detection and risk assessment activities
Author and review aggregate safety reports (PSUR/PBRER, DSUR, RMP)
Perform benefit-risk evaluations and safety trend analysis
Ensure adherence to global regulatory requirements (ICH, EMA, FDA)
Support audits, inspections, and internal quality initiatives
Mentor junior safety scientists and reviewers
Requirements
Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Medicine, or related discipline
5–10 years of experience in Pharmacovigilance / Safety Science
Strong experience with signal management and aggregate reporting
Sound knowledge of GVP Modules, MedDRA, and global PV regulations
Excellent scientific writing and stakeholder communication skills