Job Description Summary

** Only candidates in EST or CST time zones will be considered at this time.**
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.

We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $152,000.00-$228,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information

GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunity Employer