Senior Director, Pharmacovigilance (PV) Process Lead

About the role

The Senior Director, Pharmacovigilance (PV) Process Lead owns designated end-to-end (E2E) pharmacovigilance processes for critical cross-functional areas, setting strategy, accountability, and oversight to ensure consistent execution in alignment with regulatory requirements.

This role cultivates trusted, enterprise-wide relationships with key stakeholders across Takeda (e.g., Regulatory, Quality Assurance, Global Development Operations, Clinical Science, Medical Affairs, Commercial, Local Operating Companies, DD&T), demonstrating executive presence and strategic influence while serving as the central orchestrator for strong PV oversight and performance.

The PV Process Lead drives continuous process improvement, operational excellence, and efficiency by leveraging technology and AI-enabled capabilities to streamline compliant, inspection-ready E2E processes with clear roles and responsibilities. This role delivers enterprise-level impact by enabling the organization to advance patient safety globally.

Responsibilities

• Accountable for the strategy, direction, and implementation of end-to-end PV processes to ensure alignment with health authority requirements and key priorities.
• Serves as the enterprise process owner and central orchestrator for E2E PV processes, building and sustaining trusted relationships with senior cross-functional stakeholders to drive alignment, decision-making, and accountability.
• Drives cross-functional governance and operational excellence by defining roles, decision accountability, and forums that enable collaboration, transparency, and effective execution.
• Owns the design, procedural documentation, implementation, management, and oversight of designated E2E PV processes, with scope expanding as needed.
• Develops, authors, maintains, and approves procedural documents, templates/forms, training materials, and toolkits for designated E2E PV processes; provides input to associated procedural documents owned by sub-functions.
• Provides E2E PV oversight by proactively identifying risks, trends, and gaps, ensuring timely escalation, resolution, and mitigation in line with regulatory expectations.
• Serves as the main point of contact for Quality Events, CAPAs, and Change Controls related to designated processes, and represents those processes during audits and health authority inspections.
• Contributes to process impact assessments in response to changes in PV regulatory requirements and oversees implementation of necessary updates to ensure compliance.
• Champions technology and AI-enabled capabilities to drive continuous process improvement, operational excellence, and efficiency while maintaining inspection readiness.
• Provides support and back-up for other designated E2E PV processes to ensure continuity, quality, and timely execution.
• Performs other duties as requested by management.

Requirements

• Bachelor’s degree or international equivalent required; Life Sciences preferred.
• 10+ years’ experience in the pharmaceutical industry with a focus on drug safety and pharmacovigilance.
• Proven experience in a senior leadership capacity, managing matrix teams, and fostering strong partnerships with cross-functional stakeholders at the enterprise level.
• Strong strategic and critical thinking, negotiation, and influencing skills across all levels of the business.
• Excellent planning, execution, and communication skills with a drive to deliver results.
• Ability to collaborate and effectively influence various functional areas, partners, regions, and cultures.
• Healthcare business acumen with a comprehensive understanding of the pharmaceutical industry.

Schedule

This position is classified as "hybrid" in accordance with Takeda’s Hybrid and Remote Work policy.

Pay

U.S. Base Salary Range: $212,000.00 - $333,190.00. The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on factors including qualifications, relevant experience, specific skills, education, certifications, and location.

U.S.-based employees may be eligible for short-term and/or long-term incentives.

Benefits

• Medical, dental, and vision insurance.
• 401(k) plan with company match.
• Short-term and long-term disability coverage.
• Basic life insurance.
• Tuition reimbursement program.
• Paid volunteer time off.
• Company holidays.
• Well-being benefits.
• Up to 80 hours of sick time per calendar year.
• New hires eligible to accrue up to 120 hours of paid vacation.