Head of Risk Management Center of Excellence
PharmaBiotechPharmacovigilanceRegulatory AffairsQuality Assuranceheorpharmacovigilanceemacroinformaws
Job description
ROLE SUMMARY The Head of the Risk Management Center of Excellence (RMCoE) is a senior leadership role within Worldwide Safety, responsible for advancing the science and practice of benefit-risk and safety risk management across the Pfizer portfolio. This leader sets strategy and establishes fit-for-purpose standards for risk management planning, risk communication, risk minimization, and benefit-risk assessment, while ensuring that new methods and external developments are translated into practical, high-quality approaches for Pfizer programs and products. The role leads the RMCoE and provides strategic direction to Safety Risk Leads and Risk Management Product Leads supporting product risk management governance. The Head of RMCoE also serves as a key partner to business and cross-functional stakeholders for risk management planning, forecasting, portfolio oversight, and implementation, helping ensure a consistent approach from development through the post-approval setting. Success in this role requires deep expertise in pharmacovigilance and global risk management, strong scientific and regulatory judgment, and the ability to lead through influence across a highly matrixed organization. The role reports to the Head of Risk Assessment and Management (RAM). ROLE RESPONSIBILITIES Lead the RMCoE and define the strategic direction for risk management sciences, including risk management planning, risk communication, risk minimization, and benefit-risk assessment methodologies. Drive the development, adoption, and timely implementation of innovative and evidence-based risk management approaches across the Pfizer portfolio. Provide strategic guidance to Safety Risk Leads and Risk Management Product Leads supporting product risk management governance, promoting quality, consistency, and alignment in Risk Management Plans and associated strategies. Oversee approaches for clear, relevant, and effective risk communication, including methods for evaluating the effectiveness of risk minimization measures. Serve as a standing member of relevant risk management governance and advisory committees, bringing both enterprise strategy and product-level perspectives to decision-making. Lead portfolio-level oversight of RMP activities, including status visibility, planning, forecasting, performance information, and integration of relevant measures into pharmacovigilance dashboards. Oversee RMP budget planning and forecasting and work with business partners to anticipate portfolio demand and resource needs. Maintain and evolve a standardized risk management process and methodology library; enable knowledge sharing and application of lessons learned across programs and products. Monitor changes in the global regulatory, scientific, and supplier environment; assess implications for Pfizer and translate them into actionable strategies, standards, and program activities. Establish and manage internal and external collaborations that advance risk management science and generate innovative approaches that add value for patients and Pfizer products. Shape external engagement and communication strategies that strengthen understanding of Pfizer’s approach to product safety risk management. Partner with the Head of RAM and other leaders to support continuity of risk assessment and risk management strategy across the product lifecycle, from pre-approval development through post-approval use. Build, lead, coach, and develop an engaged, high-performing team; provide clear accountability, talent development, succession planning, and an inclusive environment aligned with Pfizer values. Ensure activities are conducted in accordance with applicable regulations, Pfizer policies and procedures, and quality and compliance expectations. Experience using common AI tools, including generative technologies such as ChatGPT or Microsoft Copilot, to support problem solving and enhance productivity. Demonstrated curiosity for exploring how these tools can improve outcomes and understanding of responsible AI practices, including risk management and ethical use. BASIC QUALIFICATIONS Candidate demonstrates a breadth of diverse leadership experiences and capabilities, including the ability to influence and collaborate with peers, develop and coach others, oversee and guide the work of colleagues, and deliver meaningful outcomes and business impact. Advanced degree in medicine, pharmacy, public health, epidemiology, or another relevant health or life science discipline. 10+ years of broad, progressive experience in the pharmaceutical or biotechnology industry across pharmacovigilance, drug safety, clinical development, medical, regulatory, or a closely related discipline, with substantial experience in safety risk management and benefit-risk assessment. Demonstrated experience leading global drug safety risk management planning and developing or overseeing Risk Management Plans for products across the lifecycle. Deep understanding of global pharmacovigilance and risk management requirements, including risk characterization, risk minimization, risk communication, and evaluation of effectiveness. Experience developing strategy and translating complex scientific, regulatory, and operational issues into clear decisions and executable plans. Demonstrated people leadership, including the ability to build teams, develop talent, coach senior professionals, and lead through organizational change. Proven ability to influence senior stakeholders and drive alignment and decisions in a complex, global, matrixed environment. Excellent written and verbal communication skills, with the ability to communicate complex concepts clearly to scientific, regulatory, business, and executive audiences. Ability to operate with a high degree of independence, judgment, and accountability. PREFERRED QUALIFICATIONS MD, PharmD or equivalent clinical/medical degree. Experience leading a risk management center of excellence or a comparable global pharmacovigilance, benefit-risk, or safety strategy function. <span
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