Job Description Summary The Drug Safety Medical Director works within Drug Safety & Risk Management in Global Pharmacovigilance, providing medical leadership across proactive safety surveillance and lifecycle risk management activities. The role focuses on medical review of Individual Case Safety Reports (ICSRs), safety signal detection and evaluation, and benefit-risk assessment of the assigned products in alignment with global regulatory requirements. Primary Responsibilities Serves as Medical Reviewer for Individual Case Safety Reports (ICSRs), providing expert medical assessment and clinical judgment. Gathers, reviews, and evaluates scientific and clinical data to support the development, maintenance, and update of Company Core Data Sheets (CCDS) and Company Core Safety Information (CCSI). Prepares and contributes medical safety content for key regulatory documents, including Development Safety Update Reports (DSURs), PSURs/PBRERs, RMPs, and medical expert statements. Supports safety signal detection and evaluation activities in collaboration with PV Scientists, applying data‑driven decision‑making throughout the signal management process. Authors high‑quality safety review documents, signal evaluation reports, and provides recommendations on risk management actions in partnership with cross‑functional Safety Review Teams. Provides medical expertise and collaborates with PV Scientists in the preparation of scientifically robust and regulatory‑compliant responses to safety‑related questions from health authorities. Acts as a Subject Matter Expert (SME) for Global Pharmacovigilance, offering guidance on applicable ICH, EU, US, and international clinical development and post‑marketing safety regulations, as well as product‑specific safety information. Participates in additional activities, special projects, or assignments as business needs evolve. Allocates time across responsibilities based on project scope and departmental priorities. Required Qualifications Experience in drug safety risk management and pharmacovigilance, including medical review of ICSSR, safety signal detection, and review of aggregate reports and company core safety information. Relevant experience in clinical development or medical affairs in industry or with a service provider. Minimum of 5 years of pharmaceutical/biotechnology PV experience (global experience preferred). Strong knowledge of FDA, EU, and ICH guidelines and regulations governing pharmacovigilance. Proven ability to provide sound medical assessments of Individual Case Safety Reports (ICSRs). Proficiency in using MedDRA and assigning appropriate MedDRA terms to describe adverse events, as well as WHO DD dictionary coding to capture and standardize information related to medicinal products. Desired Characteristics Strong oral and written communication skills. Demonstrated ability to analyze and resolve problems. Ability to document, plan, market, and execute programs. Established project management skills. Inclusion & Diversity GE HealthCare is an Equal Opportunity Employer where inclusion matters. 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 any other characteristic protected by law. Relocation Assistance No relocation assistance is provided. #J-18808-Ljbffr