GE HealthCare
Pay
Base pay range: $240,000.00/yr - $360,000.00/yr Job post indicates pay found in the description. Job Overview
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 is a senior leadership role; while an individual contributor position, it is mission critical for the company with responsibilities that encompass strategic planning, implementation, and management of pharmacovigilance systems and processes in compliance with regulatory requirements. The Responsible person for PV US & CAN will report to the 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. 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. 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. There is a gap for a PV leadership role in USCAN due to 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. Responsibilities
Be the expert and face of Drug Safety and PV in the US market Develop and implement pharmacovigilance strategies and systems Oversee domestic ICSRs and be 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 PV training activities, medical review, medical writing, and PV awareness/educational sessions Informal leadership in a matrix organization of case processing/distribution, customer-facing functions in other organizations, aggregate reports, clinical trial safety for USCAN studies, responses to questions from FDA Supervise follow-up with reporters Support PV inspections, audits, and health authority queries Communicate with internal stakeholders and 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 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 and USCAN experience Excellent communication and interpersonal skills, proven analytical ability, proficiency with office tools, and global safety database experience (e.g., Argus) Willingness to travel within USCAN (approximately 30%) Strong knowledge of global pharmacovigilance regulations and guidelines, especially US FDA Ability to work effectively in a cross-functional team 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: 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. GE HealthCare offers a competitive benefits package, including medical, dental, vision, paid time off, a 401(k) plan, life, disability, and accident insurance, and tuition reimbursement. 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. Compensation decisions depend on skills, qualifications, experience and location. This position may be eligible for performance-based incentives (cash bonus and/or long-term incentives). 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 legally authorized to work in the United States. Some vaccines may be mandated by customers for certain GE HealthCare employees. Relocation Assistance Provided: No Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Hospitals and Health Care Referrals increase your chances of interviewing at GE HealthCare by 2x
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Base pay range: $240,000.00/yr - $360,000.00/yr Job post indicates pay found in the description. Job Overview
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 is a senior leadership role; while an individual contributor position, it is mission critical for the company with responsibilities that encompass strategic planning, implementation, and management of pharmacovigilance systems and processes in compliance with regulatory requirements. The Responsible person for PV US & CAN will report to the 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. 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. 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. There is a gap for a PV leadership role in USCAN due to 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. Responsibilities
Be the expert and face of Drug Safety and PV in the US market Develop and implement pharmacovigilance strategies and systems Oversee domestic ICSRs and be 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 PV training activities, medical review, medical writing, and PV awareness/educational sessions Informal leadership in a matrix organization of case processing/distribution, customer-facing functions in other organizations, aggregate reports, clinical trial safety for USCAN studies, responses to questions from FDA Supervise follow-up with reporters Support PV inspections, audits, and health authority queries Communicate with internal stakeholders and 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 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 and USCAN experience Excellent communication and interpersonal skills, proven analytical ability, proficiency with office tools, and global safety database experience (e.g., Argus) Willingness to travel within USCAN (approximately 30%) Strong knowledge of global pharmacovigilance regulations and guidelines, especially US FDA Ability to work effectively in a cross-functional team 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: 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. GE HealthCare offers a competitive benefits package, including medical, dental, vision, paid time off, a 401(k) plan, life, disability, and accident insurance, and tuition reimbursement. 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. Compensation decisions depend on skills, qualifications, experience and location. This position may be eligible for performance-based incentives (cash bonus and/or long-term incentives). 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 legally authorized to work in the United States. Some vaccines may be mandated by customers for certain GE HealthCare employees. Relocation Assistance Provided: No Seniority level
Director Employment type
Full-time Job function
Research, Analyst, and Information Technology Industries
Hospitals and Health Care Referrals increase your chances of interviewing at GE HealthCare by 2x
#J-18808-Ljbffr