Senior PV Process Lead — Global Governance & AI

Takeda; Cambridge (MA); On-site; USD 212,000 - 333,000; Full time

Job summary

Takeda in Cambridge, MA seeks a Senior Director, Pharmacovigilance Process Lead to own end-to-end PV processes, set strategy, and ensure regulatory-compliant execution. You will lead cross-functional governance, build executive partnerships, and drive continuous improvement with technology and AI-enabled capabilities to maintain inspection readiness.

This role requires 10+ years in pharma PV, a Bachelor's degree, and proven leadership in matrix environments.

Qualifications

• 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 collaborations at enterprise level.
• Strong strategic thinking, negotiation, and influencing skills across all business levels.
• Excellent planning, execution, and communication skills with drive to deliver results.

Responsibilities

• Owns designated end-to-end PV processes and sets strategy and accountability.
• Builds executive-level partnerships and drives cross-functional alignment for PV oversight.
• Leads governance and operational excellence through defined roles and forums.
• Documents procedures, templates, training materials, and toolkits for PV processes.
• Identifies risks and ensures timely escalation, resolution, and regulatory compliance.
• Acts as contact for audits and inspections related to PV processes.
• Champions AI-enabled capabilities to streamline PV processes and maintain inspection readiness.

Skills

PV process ownership

executive presence

stakeholder management

cross-functional leadership

strategic influence

AI-enabled capabilities

governance

communication

risk management

Education

Bachelor’s degree

Job description

Takeda in Cambridge, MA seeks a Senior Director, Pharmacovigilance Process Lead to own end-to-end PV processes, set strategy, and ensure regulatory-compliant execution. You will lead cross-functional governance, build executive partnerships, and drive continuous improvement with technology and AI-enabled capabilities to maintain inspection readiness.

This role requires 10+ years in pharma PV, a Bachelor's degree, and proven leadership in matrix environments.