Sr. Manager, 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 within RMPs 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 establish the next generation Risk Management Center of Excellence (RMCoE).
• Partner with the RMCoE Head to instate and maintain processes and changes.
• Champions 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 the RMCoE Head, develop, evolve and implement best practices in risk management planning, including risk communication, risk minimization and benefit/risk assessment methodologies.

• In collaboration with the RMCoE Head, 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 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 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. 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 KPIs and/or regulatory commitments through maintenance and presentation of project performance dashboards.
• Create/maintain project planning and execution documentation including project charters, detailed project plans/milestones, progress reports, activity logs and deliverables, i.e. RMP submissions.
• Update/maintain assigned project‑related documentation as per defined risk management processes and file structure on designated system.
• Provide risk management education to internal and external colleagues.
• With oversight, participate in audits and inspections; prepare and coordinate responses; participate in inspection readiness.

• Bachelor's degree and 6+ years of experience or Master's degree and 5+ years of experience or Pharm.
  
  D/PHD or equivalent and 1+ years of pharmaceutical industry experience.
• Minimum 5 years of broad and progressive pharmaceutical experience in medical, clinical or pharmacovigilance with a clear focus on drug safety risk management.
• Knowledge of global safety regulations and guidelines, or equivalent.
• Demonstrated experience in global drug safety risk management planning activities and generating…