Director, Risk Management Product Lead

Why Patients Need You

At Pfizer, our Safety colleagues play a key role in connecting evidence‑based medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating the framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise, or investigating how to close gaps in data, our mission is simple: empower healthcare decisions regarding the safe and appropriate use of medicines for patients.

• Provide strategic expertise to product teams and drive the execution of Risk Management (RM) activities included within RMP (Risk Management Plans) across business units to embed a culture of innovative and efficient risk management strategies to enhance patient safety.
• Collaborate in the development of innovative methods to develop the next generation Risk Management Center of Excellence (RMCoE).
• Partner with the RMCoE Head to instate and maintain processes and changes.
• Champion for managing and building the risk management knowledge for the organization.
• Provide expertise regarding RMP requirements and implementation for pre‑marketed and post‑marketed drug products.
• Recommend appropriate risk mitigation options for drug‑related safety issues, taking into account the benefit‑risk profile of the drug and approaches used for other products internal and external to Pfizer.
• Review RMP assessment reports to determine if modifications are required.
• In collaboration with RMCoE Head, develop, evolve, and implement best practices in risk management planning, including risk communication, risk minimization, and benefit/risk assessment methodologies.

• Develop, evolve, and implement best practices in risk management planning, including risk communication, risk minimization, and benefit/risk assessment methodologies.
• Support Safety Surveillance & Risk Management (SSRM) with strategic guidance for risk management planning, considering local regulatory requirements, risk management best practices, and product‑specific risk profiles, and develop and implement RMP initiatives for products within the Pfizer portfolio.
• Serve as the key interface between RAM and the BU in matters related to oversight of implementation and tracking of commitments within the RMP; provide periodic updates regarding the status of implementation to the RMC.
• Lead PRMS using effective leadership and process management techniques, build appropriate agendas, provide draft and final minutes, and drive actions to completion; manage the storage and tracking of action items from meetings.
• Manage supplier performance/delivery relative to defined and agreed‑upon SOW; support day‑to‑day supplier communications.
• Provide regular reporting on all aspects of RMP milestones/performance per specific targets as defined by key performance indicators (KPIs) and/or regulatory commitments through maintenance and presentation of project performance dashboards.
• Create and maintain project planning and execution documentation including project charters, detailed project plans/milestones, progress reports, activity logs and deliverables, i.e., RMP submissions.
• Maintain assigned project‑related documentation as defined in risk management processes and file structure on the designated system.
• Provide risk management education to internal and external colleagues.
• Participate in audits and inspections; prepare and coordinate responses and inspection readiness.
• Act as a SME or BPO for a Safety SOP.
• Manage special projects and assist with communications.
• Provide guidance and coaching to less experienced RMPLs, participate in initial training of newly hired RMPLs, and act as first point of contact for other RMPLs in issue resolution.
• Recommend and manage external safety KOL consultations, expert working groups, and other external safety forums.
• Implement opportunities identified for consistency and standardization in Safety.
• Identify and evaluate issues and present strategies to ensure that timelines are met or accelerated.
• Influence above‑country and local individuals responsible for Safety, Regulatory, and Medical for appropriate risk management…