VP, Pharmacovigilance
Company: i-Pharm Consulting Agency
- Location: Philadelphia, United States
- Seniority: Executive
- Employment type: Full-time
- Posted: 7 days ago
- Offer language: English
Job description
Location: Philadelphia, onsite 3-4 days a week
Overview
This individual will lead a team and provide strategic and medical oversight of safety across the portfolio, driving signal detection, benefit–risk assessment, and global safety strategy.
This is a highly visible role within a fast-paced, collaborative environment, with the opportunity to influence regulatory strategy and safety governance at a global level.
Key Responsibilities
- Serve as the medical and scientific expert for safety across assigned programs (early through late-stage and/or marketed products)
- Lead signal detection, evaluation, and risk management activities, including interpretation of safety data from multiple sources
- Drive benefit–risk assessments and contribute to safety governance forums (e.g., safety review committees)
- Author and/or review key regulatory safety documents (e.g., DSURs, PBRERs, IBs, safety sections of submissions)
- Partner cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, and PV Operations to align on safety strategy
- Support global regulatory interactions, including responses to health authority queries
- Ensure inspection readiness and compliance with global pharmacovigilance regulations (FDA, EMA, ICH, etc.)
- Contribute to the development and scaling of safety processes, infrastructure, and best practices
Qualifications
- MD
- 18+ years of experience in clinical safety/pharmacovigilance within biotech or pharma
- Strong understanding of global safety regulations and reporting requirements
- Proven ability to operate in a matrixed, cross-functional environment
- Prior experience and strong track record leading regulatory filings and health authority interactions
- Team leadership experience
Why This Role
- High-impact, strategic leadership position with visibility across the organization
- Opportunity to lead and shape global safety strategy for innovative therapies
