Global PV Operations Oversight Executive

Takeda; Boston (MA); On-site; USD 238,000 - 374,000; Full time

Job summary

Takeda in Boston, MA seeks an Executive Director, Head of Pharmacovigilance Operations Oversight to lead global PV operations. You will oversee ICSR handling, regulatory reporting, and PV vendor governance while driving digital transformation and operational excellence.

The role requires 15+ years in pharma, 10+ years in PV operations, and proven leadership across geographies to ensure compliance and patient safety across the product lifecycle.

Qualifications

• Bachelor’s degree in life sciences, healthcare, pharmacy, or related discipline.
• Minimum 15 years of experience in the pharmaceutical or healthcare industry.
• Minimum 10 years of progressive experience in PV operations and safety reporting.
• Demonstrate ability to work across geographies.
• Significant experience overseeing global case processing and regulatory reporting activities.

Responsibilities

• Provide strategic leadership and oversight of Takeda's global pharmacovigilance operations.
• Oversee case intake, processing, medical coding, ICSR management, and regulatory reporting.
• Lead vendor governance and outsourcing oversight for PV service providers.
• Drive ongoing PV transformation, automation, and digital initiatives.
• Build and develop a high-performing global PV organization.

Skills

Executive leadership

Stakeholder management

Strategic planning

Regulatory knowledge

Education

Bachelor’s degree in life sciences/healthcare/pharmacy

Advanced degree preferred

Tools

Argus

ArisG

Job description

Takeda in Boston, MA seeks an Executive Director, Head of Pharmacovigilance Operations Oversight to lead global PV operations. You will oversee ICSR handling, regulatory reporting, and PV vendor governance while driving digital transformation and operational excellence.

The role requires 15+ years in pharma, 10+ years in PV operations, and proven leadership across geographies to ensure compliance and patient safety across the product lifecycle.