Head of Pharmacovigilance US & Canada

Gehealthcare; Boston (MA); Remote; USD 188,000 - 284,000; Full time

Job summary

A leading global medical technology organization seeks a Head of USCAN Pharmacovigilance to oversee safety activities and ensure compliance with regulations. This senior role demands a scientific background and extensive experience in pharmacovigilance, including direct leadership in the US and Canada. The ideal candidate will join a dynamic leadership team and contribute to strategic planning and management of pharmacovigilance processes, all while promoting safety and quality in drug monitoring.

Benefits

Medical, dental, and vision plans

401(k) plan with contributions

Education reimbursement

Qualifications

• 10+ years in Pharmacovigilance with direct USCAN leadership experience.
• Strong knowledge of global pharmacovigilance regulations and US FDA guidelines.
• Willingness to travel within USCAN (30%).

Responsibilities

• Lead and oversee all USCAN pharmacovigilance activities.
• Develop and implement pharmacovigilance strategies and systems.
• Ensure compliance with global regulatory requirements and guidelines.

Skills

Communication

Analytical skills

Interpersonal relationship

Proficiency with office packages

Experience with Chatbots

Regulatory knowledge

Cross-functional teamwork

Education

Scientific or Medical degree in human or biosciences

Tools

Argus

Job description

Jobbeschreibung Zusammenfassung

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.

Stellenbeschreibung

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.

Zusätzliche Stellenbeschreibung

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.

Zusätzliche Informationen

Vergütungsgruppe

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GE HealthCare bietet ein hervorragendes Arbeitsumfeld, berufliche Entwicklung, anspruchsvolle Karrieren und wettbewerbsfähige Vergütung. GE HealthCare ist ein href="https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf" target="_blank">Arbeitgeber, der die Chancengleichheit fördert. href="https://assets.phenompeople.com/CareerConnectResources/GE11GLOBAL/en_global/desktop/assets/images/poster_screen_reader_optimized_w_supplement.pdf" target="_blank"> Beschäftigungsentscheidungen werden unabhängig von Rasse, Hautfarbe, Konfession, nationaler oder ethnischer Herkunft, Geschlecht, sexueller Orientierung, Geschlechtsidentität oder -ausdruck, Alter, Behinderung, Status als geschützter Veteran oder anderen gesetzlich geschützten Merkmalen getroffen.

GE HealthCare beschäftigt für dieses Stellenangebot nur Mitarbeiter, die gesetzlich dazu berechtigt sind, in den USA zu arbeiten.

Während GE HealthCare derzeit keine Impfung gegen COVID-19 für US-Mitarbeiter vorschreibt, haben einige GE HealthCare-Kunden Impfvorschriften, die möglicherweise für bestimmte Mitarbeiter von GE HealthCare gelten.

Umzugshilfe bereitgestellt: Nein

Application Deadline: July 04, 2025