Global PV & REMS Compliance Leader

Praxy; Madison (NJ); Hybrid; USD 218,000 - 264,000; Full time

Benefits offered by this job

Wellbeing benefits

Retirement plan

Comprehensive insurance

Job summary

Bristol Myers Squibb seeks a senior leader to drive Pharmacovigilance quality and compliance across global safety processes in Madison, NJ. This role oversees REMS programs, risk-based monitoring, and regulatory alignment to ensure inspection readiness and continuous improvement.

The role requires ~10 years in pharmacovigilance with 7+ years in progressive leadership, plus a strong scientific background and experience with AI-enabled quality initiatives.

Qualifications

• Pharmacovigilance leadership experience in quality/compliance.
• Strong understanding of global GVP regulations and inspectorate expectations.
• Experience leveraging AI/digital tools to improve PV and REMS processes.

Responsibilities

• Lead PV quality and compliance oversight across safety outputs.
• Oversee REMS compliance programs, readiness, and tooling.
• Govern PV quality governance and enterprise quality initiatives.
• Partner with senior stakeholders to drive strategy and risk-based improvements.

Skills

PV Leadership

Quality Governance

Regulatory Compliance

Cross-functional Leadership

Digital Tools & AI

Education

Bachelor's degree in science

Post-graduate education preferred

Job description

Bristol Myers Squibb seeks a senior leader to drive Pharmacovigilance quality and compliance across global safety processes in Madison, NJ. This role oversees REMS programs, risk-based monitoring, and regulatory alignment to ensure inspection readiness and continuous improvement.

The role requires ~10 years in pharmacovigilance with 7+ years in progressive leadership, plus a strong scientific background and experience with AI-enabled quality initiatives.