Vice President Drug Safety (Pharmacovigilance)

TL;DR

Vice President Drug Safety (Pharmacovigilance): Leading drug safety operations across development and commercial portfolios with an accent on PV infrastructure, case management, and regulatory compliance. Focus on designing risk management strategies, overseeing benefit-risk assessments, and ensuring inspection readiness for global health authorities.

Location: Fully Remote, but must have authority to work in the United States

Salary: $405,000–$430,000

Company

A biopharmaceutical company specializing in the development and commercialization of therapies for rare diseases.

What you will do

• Develop and execute the strategic vision for the drug safety function in alignment with corporate goals.
• Lead PV operations, including the collection and analysis of safety data from clinical trials, post-marketing sources, and real-world evidence.
• Oversee the preparation and timely submission of expedited and periodic safety reports (ICSRs, DSURs, PSURs) to health authorities.
• Design and implement risk management strategies, including REMS, to ensure patient safety.
• Manage PV vendor partnerships, establish KPIs, and provide executive oversight of safety database infrastructure.
• Collaborate cross-functionally with Clinical Development, Regulatory Affairs, and Medical Affairs to align safety strategies.

Requirements

• MD in a relevant clinical/scientific field.
• Minimum 15 years of pharmacovigilance experience in the biopharmaceutical industry, with at least 10 years in senior leadership.
• Deep knowledge of GCP, FDA, EMA, and ICH regulations.
• Experience with safety databases, specifically ARGUS.
• Must have legal authority to work in the United States.
• Willingness to travel to company headquarters as needed.

Culture & Benefits

• Competitive base salary and comprehensive health, dental, and vision insurance.
• Generous paid time off.
• Retirement savings plan with Company Match.
• Remote-first work environment supporting work-life balance.