Head of Pharmacovigilance US & Canada

GE HealthCare; United States; Remote; USD 188,000 - 284,000; Full time

Job summary

GE HealthCare is seeking a Head of Pharmacovigilance for US & Canada. This senior leadership role entails overseeing pharmacovigilance processes, ensuring compliance with regulatory standards, and collaborating with cross-functional teams. Ideal candidates should have significant experience in Pharmacovigilance and excellent leadership capabilities. This opportunity allows for strategic influence in a rapidly developing pipeline environment.

Benefits

Medical, dental, and vision insurance

Paid time off

401(k) plan

Life and disability insurance

Tuition reimbursement

Qualifications

• 10+ years in Pharmacovigilance, Medical Affairs, or Regulatory Affairs.
• Experience with regulatory PV inspections and interactions with regulatory authorities preferred.
• Certification in pharmacovigilance or drug safety is a plus.

Responsibilities

• Lead and oversee all USCAN pharmacovigilance activities.
• Ensure compliance with global regulatory requirements.
• Monitor and evaluate the safety profile of the company's products.

Skills

Excellent communication skills

Interpersonal relationship skills

Analytical skills

Proficiency with office packages

Experience with Chatbots

Education

Scientific or Medical degree in human or biosciences

Tools

Argus

Job description

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Job Description Summary

In this role you will serve as the Responsible lead for Pharmacovigilance in the United States and Canada

Job Description Summary

In this role you will serve as the Responsible lead for Pharmacovigilance in the United States and Canada

The Head of USCAN Pharmacovigilance at GE HealthCare will lead and oversee all USCAN pharmacovigilance activities 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.

Job Description

The Responsible person for PV US & CAN 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.

There is a need for a PV leadership role in USCAN due to the accelerated growth and development of our pipeline. The Head of Pharmacovigilance USCAN at GE HealthCare will lead and oversee all USCAN pharmacovigilance activities to ensure the safety of the company's products. This role involves strategic planning, implementation, and management of pharmacovigilance systems and processes in compliance with regulatory requirements. This is a remote role with some travel. The ideal candidate will reside in the Central or Eastern Time zone.

• 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.
• Strong partnership with global leaders and team members within Global PV organization
• 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
• Communicates with internal stakeholders, customers, as needed
• Responsible for REMS and related aspects
• Responsible for quality of responses to safety questions from local health authorities
• Additional responsibilities as directed by Global Head of PV&DS
  
  

GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Qualifications

• Scientific or Medical degree in human or biosciences
• 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.

For U.S. based positions only, the pay range for this position is $188,800.00-$283,200.00 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. 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

Application Deadline: July 04, 2025

Seniority level

• Seniority level

  Director

Employment type

• Employment type

  Full-time

Job function

• Job function

  Research, Analyst, and Information Technology

• Industries

  Hospitals and Health Care

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