Job Description Summary
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The Senior Director of Risk Management within Global Pharmacovigilance provides strategic leadership and expert oversight for global product safety risk management, benefit–risk evaluation, and safety signal governance across the product lifecycle. This role ensures the highest standards of patient safety and regulatory compliance while shaping the global strategy for risk mitigation and safety communication. The Senior Director is accountable for leading the development and implementation of global risk management frameworks and for representing safety risk considerations at key governance forums, including the Product Safety Review Board (PSRB). This position reports to the Head of Global Drug Safety and Risk Management.
Responsibilities
Strategic Leadership & Governance
Serve as the strategic lead for Drug Safety & Risk Management (DSRM), driving oversight, implementation, and tracking of all global PV risk management obligations, commitments, and risk minimization measures.
Own the governance framework for safety risk communication by leading and coordinating presentations to PSRB, Quality Management Review (QMR), and PV Leadership to ensure timely escalation, clear decision‑making, and aligned risk mitigation.
Champion global benefit–risk strategy, ensuring consistent and proactive management across clinical development and post‑marketing.
Risk Management Strategy & Execution
Provide authoritative subject matter expertise on risk management principles, risk minimization strategies, and benefit‑risk assessment for all medicinal products.
Lead the development, review, and lifecycle management of Risk Management Plans (RMPs), Development RMPs, and associated regulatory documents in accordance with Good Pharmacovigilance Practices and regional regulatory expectations.
Oversee execution and completion of all post‑authorization safety commitments (e.g., PASS), including rigorous assessment of risk minimization effectiveness.
Direct the design, implementation, and lifecycle strategy of product‑specific Risk Evaluation and Mitigation Strategies (REMS) and global equivalents.
Signal Management & Safety Analytics
Provide strategic oversight for the safety signal management process, ensuring robust signal detection, evaluation, classification, validation, and communication.
Partner with safety physicians, PV scientists, and analytics teams to interpret safety data trends and ensure accurate integration of risk assessment into product labeling and RMPs.
Guide the development of analytical tools, standard outputs, and data visualizations that support comprehensive signal evaluation.
Cross‑Functional & Regulatory Collaboration
Work collaboratively with Clinical Development, Medical Affairs, Regulatory Affairs, and other key functions to ensure consistency of global risk management strategy and alignment with product benefit‑risk considerations.
Contribute to regulatory submissions (e.g., MAA, NDA, BLA) by ensuring all risk‑related components, safety narratives, and benefit‑risk assessments are accurately represented and strategically positioned.
Regulatory Intelligence & Compliance
Maintain deep knowledge of evolving global regulatory requirements related to pharmacovigilance risk management and embed intelligence into DSRM policies, processes, and strategies.
Monitor, analyze, and report key risk management performance metrics to ensure compliance with internal and external expectations.
Aggregate Safety Reporting
Oversee risk management content and strategic interpretation for aggregate safety reports including DSURs, PBRERs, and other periodic assessments, ensuring integration of current risk profiles and emerging safety data.
Scientific & Epidemiological Expertise
Provide expert epidemiological insights, including incidence and prevalence estimates, disease natural history, and relevant risk factors to support benefit‑risk assessment and risk minimization strategies.
Additional Responsibilities
Perform other duties aligned with the scope of pharmacovigilance risk management as defined in SOPs or assigned by leadership.
Qualifications
Advanced clinical degree (e.g., MD, DO, NP, PA, PharmD, MPH, PhD in a health‑related field) required.
Significant pharmaceutical/biotechnology PV experience, including clinical trial and post‑marketing experience. Global experience preferred.
Substantial experience in PV / Safety.
Strong knowledge in FDA, EU, ICH guidelines, initiatives and regulations governing pharmacovigilance.
Strong knowledge in safety signal evaluation and responses to safety requests from Health Authorities.
Pharmaceutical industry experience, with exposure to PV risk management, additional risk minimization measures / REMS preferred.
Strong track record of scientific and analytical thinking.
Experience presenting at meetings is desirable.
Inclusion and 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 other characteristics protected by law.
Benefits
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. xphnsxz 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.
Relocation Assistance
No
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