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.

• Collaborates in the development of innovative methods to develop the next generation Risk Management Center of Excellence (RMCoE).

• Partners with the RMCoE Head to instate and maintain processes and changes.

• Champions for managing and building the risk management knowledge for the organization.

• Provides expertise regarding RMP requirements and implementation for pre‑marketed and post‑marketed drug products.

• Recommends 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.

• Reviews RMP assessment reports to determine if modifications are required.

• In collaboration with RMCoE Head, develops, evolves, and implements best practices in risk management planning, including risk communication, risk minimization, and benefit/risk assessment methodologies.

• In collaboration with RMCoE Head, develops, evolves, and implements best practices in risk management planning, including risk communication, risk minimization, and benefit/risk assessment methodologies.

• Supports Safety Surveillance & Risk Management (SSRM) with strategic guidance for risk management planning, taking into consideration local regulatory requirements, risk management best practices, and product‑specific risk profile, and development and implementation of RMP initiatives for products within the Pfizer portfolio.

• Serves as the key interface between RAM and the BU in matters related to oversight of implementation and tracking of commitments included within the RMP and provides periodic updates regarding the status of implementation to the RMC.

• Leads PRMS using effective leadership and process management techniques. Builds appropriate agendas, provides draft and final minutes, and drives the actions to completion. Responsible for the storage and tracking of action items from meetings. Ensures appropriate membership attendance for internal and external meetings, including external expert engagement and briefing.

• Manages supplier performance/delivery relative to defined and agreed upon SOW; supports managing day‑to‑day supplier communications.

• Provides 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.

• Creates/maintains project planning and execution documentation including, but not limited to, project charters, detailed project plans/milestones, progress reports, activity logs, and deliverables, i.e., RMP submissions.

• Updates/maintains assigned project‑related documentation as defined in risk management processes and file structure on designated system.

• Provides risk management education to internal and external colleagues.

• With oversight, participates in audits and inspections; preparing and coordinating responses; participates in inspection readiness.

  • Acts as a SME or BPO for a Safety SOP.
  • Manages special projects and assists with communications.
  • Provides guidance and coaching to less experienced RMPLs, participates in initial training of newly‑hired RMPLs, acts as first point of contact to assist other RMPLs in issue resolution.
  • Has the foresight and judgement to recommend and then manage external safety KOL consultations, expert…