Senior Manager- Risk Management Product Lead

Why Patients Need You

At Pfizer, our Safety colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating 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.

Position Purpose

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

Job Responsibilities

• In collaboration with RMCoE Head, develops/evolves/implements best practices in risk management planning, including risk communication, risk minimization and in 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 provide 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; support 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 per 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.

Qualifications

• B.S. or M.S. in health science
• Advanced degree strongly preferred (Pharm.D, or Ph.D, or equivalents)
• Minimum 5 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance but 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 RMPs
• Demonstrated strength in analytical skills and attention to detail.
• Demonstrated strength in oral/written communication, negotiation, and interpersonal skills.
• Demonstrated organizational/project management skills.
• Familiarity with management of performance metrics
• Significant knowledge of organization processes and matr