Director, Head of PV and REMS Compliance

Bristol Myers Squibb seeks a Director to lead pharmacovigilance and REMS compliance programs, ensuring sustained regulatory compliance and quality excellence across global patient safety operations. The role combines strategic oversight of PV processes, US REMS program leadership, and cross-functional governance to maintain alignment with GVP regulations and FDA requirements.

Responsibilities

• Ensure quality and compliance across patient safety through ongoing monitoring of safety deliverables and regulatory submissions
• Translate quality findings and audit learnings into sustainable improvements across PV and REMS programs
• Lead REMS inspection readiness, compliance monitoring, and periodic assessments to identify and mitigate risks
• Chair Safety Quality Management Forum and sponsor REMS Governance Forum for effective escalation and transparency
• Develop and mentor high-performing teams, fostering quality excellence and continuous improvement culture

Requirements

• Bachelor's degree with strong scientific background; post-graduate education preferred
• Approximately 10 years of pharmacovigilance experience total
• Minimum 7 years of progressive leadership responsibility in pharmacovigilance, quality, compliance, or related disciplines
• Deep regulatory and risk-based expertise in global safety operations
• Proficiency with AI, digital tools, and data-enabled compliance solutions
• Demonstrated ability to influence cross-functional stakeholders without direct authority
• Strong oral and written communication skills with senior leadership presence