Director, Global PV Operations

GE HealthCare

. Provide strategic direction and oversight for global pharmacovigilance and drug safety operations across all regions .

Posted 4/28/2026full-timeRemote • Illinois • 🇺🇸 United StatesLead💰 $152,000 - $228,000 per yearWebsite

About the role

Key responsibilities & impact

Provide strategic direction and oversight for global pharmacovigilance and drug safety operations across all regions
Ensure compliant PV system is in place for the collection, evaluation, and submission of individual case safety reports
Collaborate closely with PV QA team to produce clear SOPs, CAPA, quality documentation and standards for Global Pharmacovigilance
Collaborate closely with the EU/UK QPPV to ensure PV Operations processes meet requirements
Ensure vendor oversight for global PV including case management activities
Own PV operational budgets, purchase orders, statements of work, and invoice oversight
Drive process optimization, standardization, and digital innovation across PV operations
Embrace LEAN methodologies and monitor operational metrics
Lead change and continuous improvement activities in global PV Operations

Requirements

What you’ll need

Healthcare Professional (RN/BSN, PharmD, MD, etc.)
Degree in Life Sciences, Biology, Business, Analytics
Minimum 10 years’ experience in PV Operations
Expert knowledge of FDA and EU legislation and ICH PV Guidelines
Knowledge of Japan PV regulations
Experience with regulatory inspections and company audits
Strong operational and project management skills
Excellent communication; executive presence with regulators and senior stakeholders
Ability to act independently and to take initiative as well as ability to work within a team

Benefits

Comp & perks

medical
dental
vision
paid time off
a 401(k) plan with employee and company contribution opportunities
life
disability
accident insurance
tuition reimbursement

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

pharmacovigilancedrug safety operationscase safety reportsSOPsCAPALEAN methodologiesoperational metricsregulatory inspectionsproject managementbudget management

Soft Skills

strategic directioncollaborationcommunicationexecutive presenceinitiativeteamworkleadershipchange managementcontinuous improvementprocess optimization

Certifications

RNBSNPharmDMD