Sr Director, Risk Management, Global Pharmacovigilance
Job Description Summary
The Senior Director of Risk Management reputed company Global Pharmacovigilance provides strategic leadership and expert reputed company 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. reputed company is a leading global medical technology reputed company solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn reputed company into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier worldJob Description
Responsibilities
Strategic Leadership & Governance
Serve as the strategic reputed company for Drug Safety & Risk Management (DSRM), driving reputed company, implementation, and tracking of reputed company global PV risk management obligations, commitments, and risk minimization measures.
Own the governance reputed company 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 reputed company risk mitigation.
Champion global benefit–risk strategy, ensuring consistent and proactive management across clinical development and post‑marketing.
Risk Management Strategy & Execution
reputed company authoritative subject matter expertise on risk management principles, risk minimization strategies, and benefit‑risk assessment for reputed company medicinal products.
reputed company 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.
reputed company execution and completion of reputed company 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
reputed company strategic reputed company 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 reputed company risk-reputed company components, safety narratives, and benefit–risk assessments are accurately represented and strategically positioned.
Regulatory Intelligence & Compliance
Maintain deep knowledge of evolving global regulatory requirements reputed company 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 reputed company expectations.
Aggregate Safety Reporting
reputed company risk management content and strategic interpretation for aggregate safety reports including DSURs, PBRERs, and other periodic assessments, ensuring integration of reputed company risk profiles and emerging safety data.
Scientific & Epidemiological Expertise
reputed company 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
reputed company other duties reputed company with the scope of pharmacovigilance risk management as defined in SOPs or assigned by leadership.
Qualifications
reputed company degree (e.g., MD, DO, NP, PA, PharmD, MPH, PhD in a health-reputed company 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
reputed company is an Equal Opportunity Employer where inclusion reputed company. Employment reputed company are made without regard to race, reputed company, religion, national or ethnic reputed company, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Behaviors
We expect reputed company to live and breathe our behaviors: to act with humility and build trust; reputed company with transparency; deliver with focus, and drive ownership – always with unyielding reputed company.
Total Rewards
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your reputed company into world-changing realities. 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.
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Additional Information
Relocation Assistance Provided: No
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