Director, Risk Management Product Lead

Locations

• United States - New York - New York City
• United States - Pennsylvania - Collegeville
• United States - Massachusetts - Cambridge

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

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/implement best practices in risk‑management planning, including risk communication, risk minimization and benefit/risk assessment methodologies.

• In collaboration with RMCoE Head, develop/evolve/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, 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.
• Serve 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 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 the actions to completion. Be responsible for the storage and tracking of action items from meetings. Ensure appropriate membership attendance for internal and external meetings, including external expert engagement and briefing.
• Manage supplier performance/delivery relative to defined and agreed upon SOW; support managing 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/maintain 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.
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