The Director, Global Pharmacovigilance (PV) Operations provides strategic and operational leadership for the global PV Operations function at GE Healthcare Pharmaceutical Diagnostics. The role defines and executes PV operational strategy, ensures end‑to‑end safety data quality, and maintains a continuous inspection‑ready state. The Director leads the optimization and modernization of PV processes and systems working in collaboration with the Global Drug Safety and Pharmacovigilance organization prioritizing efficiency, consistency, and regulatory compliance. Serves as member of the Global Pharmacovigilance leadership team to influence the operations and strategy of the department.Job Description
- Provide strategic direction and oversight for global pharmacovigilance and drug safety operations across all regions (US, EMEA, APAC, Japan).
- Ensure compliant PV system is in place for the collection, evaluation, and submission of individual case safety reports and aggregate reports in accordance with global requirements
- 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 (or designee) to ensure PV Operations processes meet the requirements of the PV system, including data quality, compliance oversight, PSMF inputs, and inspection readiness
- Ensure vendor oversight for global PV including case management activities Ensure oversight is established and effective
- Own PV operational budgets, purchase orders, statements of work, and invoice oversight
- Drive process optimization, standardization, and digital innovation across PV operations to improve efficiency, quality, and scalability
- Embrace LEAN methodologies (Establish and monitor operational metrics, dashboards, and performance indicators to support data‑driven decision‑making)
- Spokesperson for global PV Operations in company cross-functional matrix team
- Lead change and continuous improvement activities in global PV Operations and participate in external benchmarking activities to ensure PV best practices
- Partner with Medical, Regulatory Affairs, Clinical Operations, Quality, Legal, IT, Commercial, teams
- Only candidates in EST or CST time zones will be considered at this time.
Qualifications
- Healthcare Professional (RN/BSN, PharmD, MD, etc.), Degree in Life Sciences, Biology, Business, Analytics
- Minimum 10 years’ experience in PV Operations with substantial global PV Operations leadership (people + vendor + systems)
- Expert knowledge of FDA and EU legislation and ICH PV Guidelines and knowledgeable use of MedDRA are required. Knowledge of Japan PV regulations
- Experience with regulatory inspections and company audits including FDA/MHRA/EMA/Health Canada PV inspections
- Strong operational and project management skills; ability to manage multiple deliverables under tight timelines and ability to manage global projects
- Ability to act independently and to take initiative as well as ability to work within a team. Self-starter, able to work with a high degree of independence
- Excellent communication; executive presence with regulators and senior stakeholders.
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
GE Healthcare Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about GE Healthcare and has not been reviewed or approved by GE Healthcare.
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Healthcare Strength — Healthcare coverage is portrayed as comprehensive, including medical, dental, and vision options with HSA-eligible choices and preventive care coverage. Mental health and well-being support programs are also emphasized as part of the overall package.
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Retirement Support — Retirement support is described as meaningful, with a 401(k) match and additional programs such as student-loan matching in some descriptions. Legacy pension and retiree medical obligations for certain closed groups also signal continued support for long-tenured populations.
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Strong & Reliable Incentives — Variable and role-linked earning opportunities appear attractive in some job families, including high on-target earnings potential in certain sales roles. Additional role-based perks like company cars and travel-related reimbursements further increase the perceived value of total rewards in those positions.
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Every day millions of people feel the impact of our intelligent devices, advanced analytics and artificial intelligence. As a leading global medical technology and digital solutions innovator, GE Healthcare enables clinicians to make faster, more informed decisions through intelligent devices, data analytics, applications and services, supported by its Edison intelligence platform. With over 100 years of healthcare industry experience and around 50,000 employees globally, the company operates at the center of an ecosystem working toward precision health, digitizing healthcare, helping drive productivity and improve outcomes for patients, providers, health systems and researchers around the world. We embrace a culture of respect, transparency, integrity and diversity.
