Vice President, Drug Safety and Pharmacovigilance (DSPV)
Skills
- Extensive pharmacovigilance and drug safety expertise across development and commercial stages
- Deep knowledge of FDA, EMA, ICH guidelines and global safety reporting requirements
- Experience leading BLA-related safety activities and commercialization readiness
- Strong medical judgment and ability to interpret clinical trial safety data
- Proven ability to build and manage high-performing PV teams and vendors
- Excellent communication and stakeholder engagement skills
- Experience with risk management strategies and safety surveillance systems
Responsibilities
- Develop, organize, manage and maintain a fully compliant global pharmacovigilance (PV) system
- Own DSPV strategy and deliverables, including safety sections of clinical and regulatory documents (IBs, RSIs, ICFs, protocols, CSRs) and DSURs
- Provide medical and scientific leadership for product safety and lifecycle risk-benefit assessments
- Lead and grow the DSPV organization (operations and safety science) to support registrational and post-marketing activities
- Serve as lead safety representative in regulatory interactions and internal governance
- Oversee PV activities performed by external partners, vendors, and CROs
- Ensure audit and inspection readiness for the DSPV function
- Manage departmental planning, budgeting, and resource forecasting
- Chair and lead safety committees and cross-functional safety meetings
Education
- MD or equivalent clinical degree required
- Additional training or experience in rare diseases preferred
Benefits
- Equity and other variable compensation as part of total package
- Medical, dental, and vision insurance
- 401(k) plan
- Unlimited paid time off
- Parental leave
- Remote work
- Domestic & international travel (approx. 10-20%)
Average salary estimate
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