Senior Director, Pharmacovigilance Operations – Compliance

Job Description:

• Create, direct, and manage the company’s pharmacovigilance operations and compliance infrastructure and staff
• Own and drive global PV Operations strategy, planning, implementation, and management
• Advise the Head of DSPV on operational risk, resource allocation, and budget planning
• Own the DSPV Operations budget, including CRO and vendor contract spend
• Represent DSPV Operations to senior leadership and external partners
• Manage internal and external staff and own talent strategy, hiring, development, performance management, and succession planning
• Build and implement globally compliant pharmacovigilance systems
• Oversee safety systems, MedDRA updates, PV vendors, quality metrics, invoicing, and budgets
• Develop and implement inspection readiness programs and lead PV Operations during FDA, EMA, and MHRA inspections and audits
• Oversee compliant case management and timely expedited safety report submissions
• Establish systems for identifying, preventing, and correcting compliance deviations and implementing CAPAs
• Set up safety projects, Safety Management Plans, safety systems, and PV database configurations
• Draft and implement PV SOPs and work instructions
• Contribute to signal detection, benefit-risk assessment, and aggregate reporting
• Collaborate with Clinical Operations, Clinical Development, Regulatory Affairs, Legal, Medical Affairs, and Manufacturing
• Represent PV Operations on project teams, committees, and governance bodies
• Lead training and training compliance activities
• Build and oversee PV regulatory intelligence activities

Requirements:

• Healthcare or life sciences degree required
• 15+ years of pharmacovigilance experience
• 5+ years in a people-leadership role managing global PV teams
• Experience with clinical and commercial lifecycle phases
• Demonstrated experience managing PV Operations through multiple Health Authority inspections, including FDA, EMA, and MHRA
• Experience spanning clinical-stage and commercial/post-marketing environments
• Experience across multiple therapeutic areas is ideally preferred
• Skilled in process gap assessments and process enhancements
• Deep knowledge of pharmacovigilance regulations and guidelines

Benefits:

• Annual performance incentive bonus
• New hire equity
• Ongoing performance-based equity
• Medical insurance
• Dental insurance
• Vision insurance
• 401(k) match
• Flexible time off
• Paid holidays