Job Description Summary

The Chief Medical Safety Officer, Pharmaceutical Products is an executive leader reporting to the Chief Quality & Regulatory Officer at GE HealthCare. The role is accountable for medical safety leadership and oversight of the medical / clinical risk assessment process for GE HealthCare pharmaceutical products across the full product lifecycle, from clinical development through post-market surveillance.

This leader is responsible for leading a team of medical professionals and serving as the senior medical authority for benefit-risk assessment, safety signal evaluation, and safety-related decision-making for GE HealthCare’s Pharmaceutical Diagnostics business. As a core member of the GE HealthCare Product Safety Review Board (PSRB), the Chief Medical Safety Officer advises on post-market actions, market action strategy, and regulator communications, and represents GE HealthCare from a medical safety perspective in pre-market and post-market interactions with the U.S. FDA and other global regulators, as appropriate.

The role partners closely with Pharmacovigilance, Quality, Regulatory, Clinical, R&D, Medical Affairs, and business leaders. The person in this role is a U.S. board-certified physician and serves as mentor, coach, and talent developer for members of the medical safety organization.

Job Description

Scope

• Global accountability for medical safety leadership for GE HealthCare pharmaceutical products.
• Oversight of benefit-risk strategy, medical safety governance, and the medical interface to the global pharmacovigilance system.
• Medical Safety leader on the GE HealthCare Product Safety Review Board, and medical safety face of GE HealthCare to global regulators on safety matters, as requested by the Chief Quality & Regulatory Officer.

Key Responsibilities / Essential Functions

• Provide team leadership and direction to Medical Safety team - build and sustain a high-performing, inclusive, and collaborative organization.
• Ensure independent medical safety decision-making, consistent with applicable regulatory expectations and internal governance requirements.
• Serve as the senior medical authority for benefit-risk determinations and other product and patient safety-related decisions for GE HealthCare pharmaceutical products.
• Work seamlessly with the Chief Medical Safety Officer, Devices on standard processes, collaborating and sharing expertise across devices and pharmaceutical products, as relevant.
• As a core member of the GE HealthCare Product Safety Review Board (PSRB), attend PSRB meetings and advise on medical safety, market action strategy, and communications; review and approve market action letters, responses to regulator inquiries on post-market signals, and complaint closures, as appropriate.
• Provide executive medical oversight of the global pharmacovigilance system for pharmaceutical products, including case assessment support, literature surveillance, signal detection and management, aggregate reporting, and safety issue escalation and governance.
• Provide medical subject matter expertise for risk assessment and benefit-risk evaluation of GE HealthCare pharmaceutical products throughout the product lifecycle, including clinical development, regulatory submission, and post-market.
• Provide medical safety oversight for clinical development activities, including review of safety data, protocols, Investigator Brochures, safety monitoring plans, and development safety signals, in partnership with Clinical Development and Medical Affairs.
• Provide medical safety input in discussions with the U.S. FDA and other regulators in pre-market meetings and in addressing post-market safety inquiries, inspections, and safety concerns, as necessary.
• Provide medical guidance to the pharmacovigilance team regarding post-market safety assessments and to Quality and other cross-functional teams regarding complaint reviews, adverse event trends, signal evaluation, and resulting actions, including product labeling changes and risk minimization measures.
• Oversee safety-related labeling strategy and risk communication, including medically appropriate communications to regulators, healthcare professionals, customers, and patients, as applicable.
• Support aggregative periodic reporting (e.g. PSUR) and provide medical input to regulatory submissions that include clinical or safety data, as necessary.
• Support pharmacovigilance inspections and audits and help with sustained inspection readiness; support responses to findings, commitments, and CAPAs related to medical safety and pharmacovigilance activities.
• Champion the use of advanced analytics, real-world data, and digital capabilities to enhance safety surveillance and signal detection, while ens