Director, PV Hub — Global Patient Safety Leader

BioSpace

Cambridge (MA)

On-site

USD 183,000 - 305,000

Full time

9 days ago

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Job summary

Regeneron is seeking a Director, Pharmacovigilance Hub to lead Global Patient Safety Operations. You will oversee local PV execution, ensure compliance with global standards and local regulations, and coordinate with global teams to integrate country data into the PV system.

You will build and scale a high-performing team, manage relationships with regulators, and drive continuous improvement across LATAM, US, and Canadian markets. Role is onsite four days a week in multiple locations.

Qualifications

  • Bachelor's degree required; advanced degree preferred.
  • 12+ years PV experience with patient safety achievements.
  • LATAM/US/Canada market experience preferred.

Responsibilities

  • Maintain understanding of local legislation and requirements, informing WWOO leadership.
  • Track local process status, changes and risks to drive hub consistency and improvement.
  • Develop innovative approaches to core PV activities, including AI.
  • Ensure country compliance with global PV quality system and handle inspections and CAPAs.
  • Coordinate with GPS and non-GPS teams to align local requirements with global.

Education

Bachelor's Degree (12+ years PV)

Job description

Regeneron is seeking a Director, Pharmacovigilance Hub to lead Global Patient Safety Operations. You will oversee local PV execution, ensure compliance with global standards and local regulations, and coordinate with global teams to integrate country data into the PV system.

You will build and scale a high-performing team, manage relationships with regulators, and drive continuous improvement across LATAM, US, and Canadian markets. Role is onsite four days a week in multiple locations.

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