Senior Director, Risk Management, Global Pharmacovigilance
GE HealthCare
full-time
Posted on:
Location Type: Remote
Location: United States
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Job Level
About the role
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Perform other duties aligned with the scope of pharmacovigilance risk management as defined in SOPs or assigned by leadership.
Requirements
- 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.
Benefits
- Competitive salary
- Flexible working hours
- Professional development budget
- Home office setup allowance
- Global team events
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
Risk Management Plans (RMPs)Good Pharmacovigilance PracticesRisk Evaluation and Mitigation Strategies (REMS)Safety signal managementPharmacovigilanceBenefit-risk assessmentData visualizationAnalytical tools developmentRegulatory submissionsEpidemiological insights
Soft Skills
Strategic oversightCollaborationCommunicationLeadershipAnalytical thinkingPresentation skillsDecision-makingRisk mitigationProblem-solvingInterpersonal skills
Certifications
MDDONPPAPharmDMPHPhD