Executive Director, Head of Global Pharmacovigilance Operations, Quality & Compliance

Ultragenyx

Remote regions

US

Salary range

$301,100–$371,900/yr

Benefits

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Position Summary:

  • Accountable for strategic leadership and operational effectiveness of global PV Operations, Quality & Compliance.
  • Ensures PV system scalability, compliance, and inspection readiness for portfolio growth.
  • Directs case processing, vendor oversight, PSMF management, and quality/compliance systems.

Responsibilities:

  • Build and mentor the global PV function, aligning with corporate long-range growth plans.
  • Lead PV operations including intake, triage, case processing, and regulatory reporting.
  • Oversee vendor governance, safety agreements, and partner compliance.
  • Manage PV quality systems, deviations, CAPAs, audits, and inspection preparedness.

Qualifications:

  • Minimum 15 years of global DSPV experience with advanced scientific degree.
  • Direct experience in PV Operations, vendor management, and GVP quality/compliance in biopharma.
  • Proven leadership of global teams and cross-functional collaboration.
  • Experience with FDA/EMA inspections and PV system governance.

Benefits:

  • Generous vacation time and public holidays observed by the company.
  • Long term incentive and Employee stock purchase plans.
  • Employee wellbeing benefits, fitness reimbursement, and tuition sponsoring.
  • Professional development plans and volunteer days.

Ultragenyx

Ultragenyx is a biopharmaceutical company focused on developing life-changing treatments for rare diseases. They foster a supportive and inclusive culture of learning and growth, aiming to be an organization where employees can thrive personally and professionally.

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