Global Pharmacovigilance Operations Executive

JobRx, Inc.; Boston (MA); On-site; USD 238,000 - 374,000; Full time

Benefits offered by this job

Health benefits

401(k) match

Disability insurance

Tuition reimbursement

Paid vacation

Job summary

Takeda in Boston, MA is seeking an Executive Director, Head of Pharmacovigilance Operations Oversight to provide strategic leadership for global safety operations across the product lifecycle. You will oversee case processing, ICSR management, regulatory reporting, vendor governance, and inspection readiness while driving digital transformation and continuous improvement.

This role partners with cross‑functional leaders to ensure high standards of quality, patient safety, and regulatory

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.
• Demonstrated experience managing global CROs, strategic vendors, and outsourcing partnerships.

Responsibilities

• Lead global PV operations strategy, governance, and operating model.
• Oversee vendor governance, outsourcing partnerships, and budget management.
• Ensure compliance with FDA, EMA, ICH, and international requirements; maintain inspection readiness.
• Drive continuous improvement, digital transformation, and data-driven decision making.
• Lead and develop a high-performing, global PV organization.

Skills

Leadership

Communication

Stakeholder management

Vendor governance

Education

Bachelor's degree in life sciences

Advanced degree preferred

Tools

Argus

ArisG

Job description

Takeda in Boston, MA is seeking an Executive Director, Head of Pharmacovigilance Operations Oversight to provide strategic leadership for global safety operations across the product lifecycle. You will oversee case processing, ICSR management, regulatory reporting, vendor governance, and inspection readiness while driving digital transformation and continuous improvement.

This role partners with cross‑functional leaders to ensure high standards of quality, patient safety, and regulatory