Principal Scientist, Safety
Core
Lead scientific and clinical expertise 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 / Neurological, psychiatric, endocrine, and immunological disorders
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Pharmacovigilance compliance, signal detection and evaluation, aggregate safety data review, SOP development, regulatory authority inspection support, drug safety database management (ARISg), safety coding dictionaries (MedDRA, WHODRUG), scientific data synthesis, cross-functional collaboration
Preferred skills
Healthcare professional experience, vendor management, GVP process improvement initiatives
Technologies
ARISg, MedDRA, WHODRUG
Responsibilities
Lead safety scientist for assigned programs, conduct literature reviews, prepare periodic safety reports, perform signal detection and evaluation, participate in Data Monitoring Committee meetings, contribute to SOP development, support case processing activities
Seniority
Senior, hands-on IC with strategic input
