PV Process Lead: Strategy, Governance & AI-Driven Excellence

Takeda; Cambridge (MA); Hybrid; USD 200,000 - 333,000; Full time

Job summary

Takeda in Cambridge, MA is seeking a Senior Director, Pharmacovigilance Process Lead to own end-to-end PV processes, drive strategy, and ensure regulatory compliance across cross-functional teams.

You will lead governance, develop procedural documents, partner with Quality, Regulatory, and Development teams, and advance continuous improvement through technology and AI-enabled capabilities to ensure inspection readiness and patient safety.

Qualifications

• Bachelor’s degree or international equivalent; 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.

Responsibilities

• Owns end-to-end PV processes, setting strategy and oversight.
• Serve as enterprise process owner; build relationships with senior stakeholders across the organization.
• Define roles, accountability, and forums for collaboration and effective execution.
• Own design, documentation, implementation, management, and oversight of designated E2E PV processes.
• Develops procedures, templates, training materials, and toolkits for designated E2E PV processes.
• Provides E2E PV oversight; proactively identify risks, trends, and gaps; ensure timely escalation and mitigation.
• Serves as main contact for Quality Events, CAPAs, and Change Controls during audits/inspections.
• Contributes to process impact assessments for regulatory changes and oversees updates.
• Champions technology and AI-enabled capabilities to improve processes and maintain inspection readiness.
• Provides back-up for other PV processes to ensure continuity.
• Performs other duties as requested by management.

Skills

Strategic thinking

Executive presence

Negotiation

Influencing

Leadership

Cross-functional collaboration

Communication

Planning & execution

Health care knowledge

Stakeholder management

Education

Bachelor's degree

Job description

Takeda in Cambridge, MA is seeking a Senior Director, Pharmacovigilance Process Lead to own end-to-end PV processes, drive strategy, and ensure regulatory compliance across cross-functional teams.

You will lead governance, develop procedural documents, partner with Quality, Regulatory, and Development teams, and advance continuous improvement through technology and AI-enabled capabilities to ensure inspection readiness and patient safety.