GE HealthCare USCAN Head Drug Safety Pharmacovigilance 

Remote, Remote 

955574807

In this role you will serve as the Responsible person for Pharmacovigilance, United States and CanadaThe 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.
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

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.

Application Deadline: April 09, 2025