Patient Safety Senior Medical Director
Vertex Pharmaceuticals · Boston, MA
SafetyFull-time$276k–$414kCompany career page
The apply link worked recently (not employer-confirmed).
Role summary
Vertex Pharmaceuticals seeks a Patient Safety Senior Medical Director to lead safety and risk management activities for assigned pharmaceutical products across pre- and post-approval stages. The role requires medical expertise in clinical safety evaluation, regulatory submissions, and cross-functional team leadership in Boston.
What they're looking for
- MD, DO, or equivalent non-US medical degree
- 7+ years of relevant experience or equivalent education and experience combination
- Advanced knowledge of General Medicine and benefit-risk assessment principles
- Solid understanding of GCP, ICH guidelines, and global regulatory requirements
- Advanced experience evaluating safety data, adverse events, and clinical study documents
- Strong written and oral communication skills for complex topics and senior stakeholder engagement
- Sound independent judgment and decision-making in matrix environments
What you'll be doing
- Lead safety representation on cross-functional clinical teams and programs for assigned products.
- Conduct medical evaluation of safety data from toxicology, non-clinical studies, and product quality complaints.
- Provide strategic leadership on periodic safety reports, risk management deliverables, and product labeling.
- Review individual case safety reports from clinical trials and post-marketing sources with timely medical judgment.
- Participate in protocol development, safety data analysis, and regulatory submissions including Advisory Committee meetings.
Privacy & handoff
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