Principal Scientist, Safety
Core
Provide scientific/clinical expertise and support for clinical and post-market pharmacovigilance, including signal management, benefit-risk evaluations, and authoring periodic safety reports.
Role type
Principal Scientist, Safety (Pharmacovigilance)
Builds
Periodic safety reports (PADER, DSUR), safety evaluations, and regulatory submissions for assigned programs.
Domain
Biopharmaceuticals / Pharmacovigilance
Required skills
Pharmacovigilance compliance, signal detection and evaluation, aggregate safety data review, SOP development, regulatory authority inspection support, drug safety database management (ARISg), MedDRA/WHODRUG coding, clinical document review.
Preferred skills
Healthcare professional experience, vendor management, GVP process improvement initiatives.
Technologies
ARISg, MedDRA, WHODRUG
Responsibilities
Lead preparation of periodic safety reports (PADER, DSURs), perform signal detection and evaluation, conduct literature reviews, participate in Data Monitoring Committee meetings, contribute to SOP development, support case processing activities.
Seniority
Principal, hands-on IC with strategic input