GE HealthCare
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; although 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. Responsibilities
Be the expert and face of Drug Safety and PV in the US market Develop and implement pharmacovigilance strategies and systems Oversees domestic ICSR processing 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 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 include PV training, medical review, medical writing, and PV awareness/educational sessions Provide informal leadership within a matrix organization (case processing/distribution, customer-facing functions in other organizations, aggregate reports, and clinical trial safety for USCAN); respond to FDA questions as needed 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 of 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) at local, regional or global levels; USCAN experience preferred Excellent communication and interpersonal skills; proven analytical abilities; proficient with office software; experience with global safety databases (e.g., Argus) Willingness to travel within USCAN (about 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 Additional Information
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 where applicable. Some customers may have vaccination mandates that apply to GE HealthCare employees. Relocation assistance: No.
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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; although 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. Responsibilities
Be the expert and face of Drug Safety and PV in the US market Develop and implement pharmacovigilance strategies and systems Oversees domestic ICSR processing 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 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 include PV training, medical review, medical writing, and PV awareness/educational sessions Provide informal leadership within a matrix organization (case processing/distribution, customer-facing functions in other organizations, aggregate reports, and clinical trial safety for USCAN); respond to FDA questions as needed 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 of 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) at local, regional or global levels; USCAN experience preferred Excellent communication and interpersonal skills; proven analytical abilities; proficient with office software; experience with global safety databases (e.g., Argus) Willingness to travel within USCAN (about 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 Additional Information
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 where applicable. Some customers may have vaccination mandates that apply to GE HealthCare employees. Relocation assistance: No.
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