USCAN Head of Drug Safety and Pharmacovigilance

Job Description SummaryIn this role you will serve as the Responsible person for Pharmacovigilance, United States and Canada

The Head of Pharmacovigilance 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.

The Responsible person for PV USCAN 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.

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.

Job Description

• 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
• 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

Qualifications

• Scientific or Medical degree in human or biosciences
• 10+ years in Pharmacovigilance, Medical Affairs and or, Regulatory Affairs in Pharmaceutical company or CRO, (at least 5 years in Pharmacovigilance) at local, regional or global levels, and ideally several
• 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.

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For U.S. based positions only, the pay range for this position is $160,000.00-$240,000.00 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.

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: Yes

Application Deadline: April 09, 2025 Apply