Global Pharmacovigilance Strategy Lead

i‑Pharm Consulting; Philadelphia (Philadelphia County); On-site; USD 210,000 - 270,000; Full time

Job summary

i‑Pharm Consulting in Philadelphia seeks a seasoned Medical Director of Safety to lead a team and provide strategic and medical oversight of safety across the portfolio, guiding signal detection, benefit–risk assessment, and global safety strategy.

This high-visibility role offers influence on regulatory strategy and safety governance at a global level, with opportunities to shape safety processes and ensure inspection readiness across regions.

Qualifications

• MD with leadership in pharmacovigilance and clinical safety initiatives.
• 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.
• Leadership of regulatory filings and health authority interactions.
• Team leadership experience.

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.

Skills

Clinical safety

Pharmacovigilance

Regulatory strategy

Team leadership

Cross-functional collaboration

Education

MD

Job description

i‑Pharm Consulting in Philadelphia seeks a seasoned Medical Director of Safety to lead a team and provide strategic and medical oversight of safety across the portfolio, guiding signal detection, benefit–risk assessment, and global safety strategy.

This high-visibility role offers influence on regulatory strategy and safety governance at a global level, with opportunities to shape safety processes and ensure inspection readiness across regions.