Principal Scientist, Safety

About The Role
Provide scientific/clinical expertise, strategic input, and support for deliverables and activities associated with clinical and post-market pharmacovigilance, including signal management, safety and benefit-risk evaluations, and authoring periodic safety reports (e.g., PADER, DSUR). Key contributor to SOP development and revisions. May support DSPV Operations and assist with case processing as needed.

Your Contributions (Responsibilities)
- Safety Scientist Lead for assigned programs/studies; provide clinical and operational safety support to Clinical Development (e.g., protocol/study report/Investigator Brochure/informed consent content review)
- Conduct literature review for assigned programs
- Lead preparation of periodic safety reports (e.g., PADER, DSURs) per regulatory requirements and SOPs
- Collaborate with DSPV Medical Director on aggregate safety data review/interpretation
- Collaborate with DSPV Medical Director on signal detection and evaluation
- Participate in independent Data Monitoring Committee meetings (as applicable)
- Contribute to SOP and guidelines development/revisions
- Work in multidisciplinary teams to execute clinical trials
- Support DSPV Operations with case processing activities as needed
- Other duties as assigned

Requirements / Qualifications
- BS/BA or RN in related scientific field + 8+ years drug safety in biotech/pharma, including 3+ years pharmacovigilance compliance (plus experience with GVP inspections, process improvement; drug safety databases such as ARISg—preferred healthcare professional/vendor management)
OR Master’s degree + 6+ years
OR PhD/PharmD + 4+ years
- Strong leadership, communication, and cross-functional collaboration
- Strong US/EU pharmacovigilance regulatory knowledge and pharmacovigilance practices
- Ability to evaluate/interpret/synthesize scientific data
- Proficiency with MedDRA/WHODRUG
- Expertise in individual safety case report processing (triage, data entry, quality review, submission)