Head of Pharmacovigilance, USCAN

Job Description SummaryThe Head of Pharmacovigilance at GE HealthCare will lead and oversee all US & Canada (USCAN) pharmacovigilance activities for the Pharmaceutical Diagnostics business to ensure the safety of the company's products. This is a senior leadership role, and although an individual contributor position, it is mission critical for the company with responsibilities that encompasses strategic planning, implementation, and management of pharmacovigilance systems and processes in compliance with regulatory requirements. This role will report to Head of Global Pharmacovigilance and Drug Safety within the GEHC Global Medical Services organization, and will be a permanent member of the USCAN Leadership Team.

Job Description

We are seeking a medically trained Pharmacovigilance Physician to lead and support drug safety activities across the United States and Canada, with additional responsibilities in global safety oversight. This role ensures compliance with FDA, Health Canada, and ICH pharmacovigilance regulations, contributing to the safety strategy of both marketed and investigational products. The ideal candidate will bring clinical expertise, regulatory awareness, and strategic insight to assess benefit-risk profiles, manage safety signals, and support regulatory submissions and inspections. 

• Be the expert and face of Drug Safety and PV in the US market
• Develop and implement pharmacovigilance strategies and systems
• Oversees domestic ICSRs and is responsible for overall quality of ICSR submissions
• Ensure compliance with global regulatory requirements and guidelines
• Rigorously ensure the collection, analysis, and reporting of adverse event data to the highest GEHC standards
• Collaborate with cross-functional teams, including commercial, medical, clinical, regulatory, and quality assurance
• Monitor and evaluate the safety profile of the company's products
• Stay updated on changes in pharmacovigilance regulations and guidelines
• Day-to-day responsibilities, including but not limited to: PV training activities, medical review, medical writing, perform PV awareness and educational sessions
• Informal leadership (matrix organization of consisting of case processing/distribution, customer-facing functions in other organizations, aggregate reports, clinical trial safety for studies in USCAN, responses to questions from FDA)
• Supervises follow-up with reporters
• Support PV inspections, audits and health authority queries
• Communicates with internal stakeholders, customers, as needed
• Review and medically assess Individual Case Safety Reports (ICSRs), including serious and unexpected adverse events.
• Support Risk Evaluation and Mitigation Strategies (REMS) and Periodic Benefit-Risk Evaluation Reports (PBRERs).
•  Responsible for quality of responses to safety questions from local health authorities
• Additional responsibilities as directed by Global Head of PV&DS

Global Safety Collaboration

• Participate in global signal detection, risk management planning, and aggregate report preparation (e.g., DSURs, PSURs).
• Provide medical input into global safety governance meetings, including Safety Review Teams and Risk Management Committees.
• Collaborate with EU QPPV and regional safety leads to ensure harmonized safety strategies across geographies.

 

Qualifications

• MD or equivalent medical degree required;
• 10+ years in Pharmacovigilance, Medical Affairs and/or Regulatory Affairs in a Pharmaceutical company or CRO, (with at least 10 years in Pharmacovigilance) at local, regional or global levels, and ideally several, with direct USCAN experience
• Excellent communication and interpersonal relationship skills, proven analytical skills, proven proficiency with office packages, demonstrable experience with Chatbots (ChatGPT, Copilot, Claude, Perplexity, etc.) and global safety data base experience (e.g. Argus)
• Willingness to travel within USCAN (30%)
• Strong knowledge of global pharmacovigilance regulations and guidelines, especially US FDA
• Ability to work effectively in a cross-functional team environment

 

Preferred Qualifications:

• Experience in a leadership role within a pharmaceutical or biotechnology company
• Experience with regulatory PV inspections and interactions with regulatory authorities
• Certification in pharmacovigilance or drug safety

 

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership –always with unyielding integrity.

 

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

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 $240,000.00-$360,000.00 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

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.