Senior PV Process Lead - Enterprise E2E & AI-Driven Ops

Takeda Pharmaceutical Co.; Kendall Square (MA); On-site; USD 212,000 - 333,000; Full time

Job summary

Takeda Pharmaceutical Co. in Cambridge, MA is seeking a Senior Director, PV Process Lead to own end-to-end pharmacovigilance processes.

You will set strategy, establish governance, and drive cross-functional accountability across regulatory, QA, GDO, Clinical Science, and Medical Affairs to ensure inspection readiness. You will lead documentation, training, audits, and changes in PV processes, leveraging technology and AI to improve efficiency and risk management.

Qualifications

• Bachelor’s degree or international equivalent; Life Sciences preferred.
• 10+ years’ experience in the pharmaceutical industry focusing on drug safety and pharmacovigilance.

Responsibilities

• Owns end-to-end PV processes and drives governance, accountability, and decision forums.
• Develops, updates, and approves procedural documents and training materials.
• Provides PV oversight for audits/inspections and responds to regulatory changes.
• Champions technology and AI-enabled capabilities to improve efficiency and inspection readiness.
• Leads cross-functional collaboration across regions and functions to resolve risks and drive alignment.

Skills

PV process knowledge

GVP/GCP regulations

Executive leadership

Cross-functional collaboration

Strategic thinking

Communication

Project management

Global regulatory environment

Digital/AI-enabled process improvement

Pharma industry expertise

Education

Bachelor’s degree (Life Sciences preferred)

10+ years in pharmaceutical industry (drug safety/PV)

Job description

Takeda Pharmaceutical Co. in Cambridge, MA is seeking a Senior Director, PV Process Lead to own end-to-end pharmacovigilance processes.

You will set strategy, establish governance, and drive cross-functional accountability across regulatory, QA, GDO, Clinical Science, and Medical Affairs to ensure inspection readiness. You will lead documentation, training, audits, and changes in PV processes, leveraging technology and AI to improve efficiency and risk management.