Senior Director, Pharmacovigilance (PV) Process Lead

POSITION OBJECTIVES

• Own designated end-to-end (E2E) pharmacovigilance (PV) processes for critical cross-functional areas; set strategy, accountability, and oversight to ensure consistent execution in alignment with regulatory requirements.
• Cultivate trusted enterprise-wide relationships with key stakeholders across Takeda (Regulatory, Quality Assurance, Global Development Operations, Clinical Science, Medical Affairs, Commercial, Local Operating Companies, DD&T); serve as central orchestrator to ensure strong PV oversight and performance by identifying risks, driving issue resolution, and promoting alignment and decision-making.
• Drive continuous process improvement/operational excellence/efficiency by leveraging technology and AI-enabled capabilities to enable streamlined, compliant, inspection-ready E2E processes with clear roles and responsibilities.

POSITION ACCOUNTABILITIES

• Accountable for end-to-end process strategy, direction, and implementation aligned with health authority PV requirements.
• Enterprise process owner/central orchestrator for E2E PV processes; drive alignment, decision-making, and accountability.
• Drive cross-functional governance and operational excellence (roles, decision accountability, forums).
• Own design, documentation, implementation, management, and oversight of designated E2E PV processes.
• Develop/author/maintain/approve procedural documents, templates/forms, training materials, and toolkits; provide input to related sub-function documents.
• Provide E2E PV oversight by proactively identifying risks, trends, and gaps; ensure timely escalation, resolution, and mitigation.
• Main point of contact for Quality Events, CAPAs, and Change Controls; represent processes during audits and health authority inspections.
• Contribute to process impact assessments for changes in PV regulatory requirements; oversee implementation of updates.
• Champion technology/AI-enabled capabilities to maintain inspection readiness.
• Provide support/back-up for other designated E2E PV processes as needed.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS

• Bachelor’s degree or international equivalent required; Life Sciences preferred.
• 10+ years in pharmaceutical industry with focus on drug safety and pharmacovigilance.
• Senior leadership experience managing matrix teams; strong enterprise cross-functional partnerships.
• Strong strategic/critical thinking, negotiation, and influencing skills.
• Excellent planning, execution, and communication skills; results-driven.
• Ability to collaborate and influence across functions, partners, regions, and cultures.
• Healthcare business acumen and comprehensive understanding of the pharmaceutical industry.