Senior Director, Pharmacovigilance (PV) Process Lead
About The Position
Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as a Senior Director, Pharmacovigilance Process Lead in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, bold mission. POSITION OBJECTIVES: The Senior Director, Pharmacovigilance (PV) Process Lead: Owns designated end-to-end (E2E) pharmacovigilance (PV) processes for critical cross-functional areas, setting the strategy , accountability , and oversight to ensure consistent execution , in alignment with regulatory requirements. 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 to ensure strong PV oversight and performance , identifying risks, driving issue resolution, and promoting alignment and decision-making among cross-functional stakeholders. Drives continuous process improvement , operational excellence, and efficiency by leveraging technology and AI-enabled capabilities to enable streamlined, compliant, and inspection ready E2E processes with clear roles and responsibilities. By driving governance, alignment, and execution across critical cross-functional PV processes , this role delivers enterprise-level impact . With strong partnerships and a continuous improvement and technology/digital mindset, the PV Process Lead enables the organization to deliver on key priorities , operational excellence, and advance patient safety across the business globally.
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 and collaborations with cross-functional stakeholders at 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.
- Health care business acumen with a comprehensive understanding of the pharmaceutical industry.
Responsibilities
- Accountable for the strategy, direction, and implementation of end-to-end processes to ensure they are in line with health authority PV requirements and deliver on 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, driving alignment, decision-making, and accountability across the organization.
- 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 to other E2E processes, as needed.
- Develops, authors, maintains, and approves procedural documents, associated templates/forms, training materials, and other toolkits for designated E2E PV processes.
- Provides input to associated procedural documents owned by sub-functions in relation to designated E2E PV processes.
- Provides E2E PV oversight for designated processes by proactively identifying risks, trends, and gaps, and 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 the designated processes, and represents those E2E processes during audits and health authority inspections.
- Contributes to process impact assessments in response to changes in PV regulatory requirements identified through Takeda’s regulatory intelligence activities and oversees implementation of the necessary updates to ensure these processes comply with new regulatory requirements.
- Champions technology and AI-enabled capabilities to drive continuous process improvement, operational excellence, and efficiency by streamlining the E2E processes, defining clear roles and responsibilities, and ensuring that they are in-line with regulatory requirements to maintain inspection readiness at all time.
- Provides support and back-up for other designated E2E PV processes, as needed, to ensure continuity, quality, and timely execution.
- Performs other duties as requested by management.
Benefits
- medical, dental, vision insurance
- a 401(k) plan and company match
- short-term and long-term disability coverage
- basic life insurance
- a tuition reimbursement program
- paid volunteer time off
- company holidays
- well-being benefits
- up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation
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What This Job Offers
Job Type
Full-time
Career Level
Senior
