Senior Director, Pharmacovigilance (PV) Process Lead

USA - 3316 Takeda Development Center Americas, Inc.; Kendall Square (MA); Hybrid; USD 212,000 - 333,000; Full time

Job summary

Takeda Cambridge, MA invites a Senior Director, Pharmacovigilance Process Lead to oversee end-to-end PV processes, shaping strategy and ensuring regulatory compliance. You will partner with Regulatory, Quality, Global Development Operations and others to drive governance and continuous improvement.

In this hybrid role, you will own process documentation, training materials, and CAPA coordination, leading enterprise PV initiatives and safeguarding patient safety across regions.

Qualifications

• 10+ years in the pharmaceutical industry with PV focus.
• Senior leadership experience and matrix team management.
• Strong partnerships with cross-functional stakeholders at enterprise level.
• Excellent planning, execution, and communication skills.

Responsibilities

• Owns end-to-end PV processes, setting strategy and oversight.
• Builds relationships with Regulatory, Quality Assurance, and Global Development Ops.
• Champions governance, roles, and forums for collaboration and accountability.
• Maintains procedural documents, templates, training materials and toolkits.
• Provides PV oversight for audits, CAPAs, and Change Controls.

Skills

Pharmacovigilance

Leadership

Cross-functional collaboration

Regulatory knowledge

Strategic thinking

Education

Bachelor's degree

Job description

Job Description 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.

POSITION ACCOUNTABILITIES:

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.

EDUCATION, BEHAVIORAL COMPETENCIES AND SKILLS:

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

Empowering Our People to Shine Discover more at takedajobs.com

Takeda Compensation and Benefits Summary

We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.

For Location: Cambridge, MA 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 a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job.The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.

For information about our benefits, please click here.

EEO Statement

Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.

Locations Cambridge, MA Worker Type Employee Worker Sub-Type Regular Time Type Full time Job Exempt Yes It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Takeda is an industry-leading, global pharmaceutical company with an unwavering dedication to putting patients at the center of everything we do. We live our values of Takeda-ism – Integrity, Fairness, Honesty, and Perseverance – and are united by our mission to strive towards Better Health and a Brighter Future for people worldwide through leading innovation in medicine. Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. At Takeda, you will make an impact on people’s lives – including your own.

Takeda is an equal opportunity employer. For applicants of U.S and Puerto Rico positions: Click here to learn about our commitment to Equal Employment Opportunity (EEO). If you are limited in the ability to use our job application tool, or otherwise require a reasonable accommodation for a disability please click here.