• The Vice President of Pharmacovigilance will provide strategic leadership and oversight of all global pharmacovigilance and drug safety operations
• This executive will ensure the company's compliance with worldwide safety regulations, guide safety risk management strategies across all product life cycles, and foster a high-performance safety culture
• Acting as the primary safety authority for the organization, the VP of PV will partner with cross-functional stakeholders to safeguard patients while enabling business objectives
• Strategic Leadership & Governance
• Define and execute the global PV strategy aligned with corporate goals and regulatory expectations
• Lead the design and continuous improvement of the PV system, ensuring compliance with FDA, EMA, ICH, and other global health authority requirements
• Serve as the company's senior safety spokesperson in regulatory inspections, audits, and external meetings
• Chair the Safety Governance Board and oversee all risk–benefit assessments
• Operational Oversight
• Lead PV teams responsible for case processing, signal detection, aggregate reporting, and risk management
• Ensure timely submission of expedited safety reports, periodic safety update reports (PSURs/PBRERs), and development safety update reports (DSURs)
• Oversee vendor management for outsourced PV activities, ensuring quality and compliance
• Implement effective pharmacovigilance quality management systems, including SOPs, training, and CAPA processes
• Cross-functional Collaboration
• Partner with Clinical Development, Regulatory Affairs, Medical Affairs, Quality, and Commercial teams to ensure integrated safety strategies
• Support labeling decisions, safety-related communications, and benefit–risk assessments for regulatory filings
• Engage with KOLs, regulatory agencies, and industry bodies to represent the company's safety position
• Build, inspire, and mentor a high-performing PV organization
• Foster a culture of operational excellence, scientific rigor, and regulatory compliance

Plan and manage PV budgets and resource allocation

• MD, PharmD, or equivalent advanced degree in a medical/scientific discipline
• 15+ years in pharmacovigilance or drug safety, with at least 8 years in senior leadership roles
• Deep knowledge of global PV regulations (FDA, EMA, ICH E2E, CIOMS)
• Proven experience managing safety across both clinical development and post-marketing environments
• Exceptional leadership skills with the ability to inspire and manage diverse teams
• Strong track record of successful regulatory inspections and audits
• Experience in biotech, specialty pharmaceuticals, or immunology/oncology therapeutic areas
• Board certification in a relevant specialty

Previous leadership in a mid-to-large size pharma or biotech organization

• Compensation & Benefits
• Competitive executive-level base salary and performance bonus
• Long-term equity incentives
• Comprehensive health, dental, and retirement benefits

Relocation assistance (if applicable)