Senior Manager, Risk Management Product Lead

The Risk Management Product Lead (RMPL) will be responsible for managing product-related and non-product projects to support the Pharmacovigilance (PV) department's disease areas, Safety Process and Risk Research (SPRR), and projects conducted in Epidemiology, European Qualified Person for Pharmacovigilance/Policy and business unit safety strategy business as appropriate.

Risk Management Product Leads will drive the execution of Risk Management (RM) activities including but not limited to REMS (Risk Evaluation and Mitigation Strategy)/RMP (Risk Management Plans) across business units to embed a culture of innovative and efficient risk management strategy. Collaborate in the development of innovative methods to develop the next generation RM CoE. Partner with the RM Program Director to instate and maintain processes and changes. Champions for managing and building the risk management knowledge for the organization.

ROLE RESPONSIBILITIES

• Provides strategic expertise to product teams and will 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.
  
• Supports Safety Surveillance and 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 RMCoE and the Business Unit (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 Risk Management Committee (RMC)
  
• Leads Product Risk Management Subteam 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 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 OR 3 years with 1 year experience with a regulatory authority
  
• 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 matrix-based decision-making is required.
  
• Project management certification (PMP) and Six Sigma Certification preferred.
  

Additional Job Information:

• Last Date to Apply: May 26, 2023
  

The annual base salary for this position ranges from $106,300.00 to $177,100.00. In addition, this position offers an annual bonus with a target of 15.0% of the base salary and eligibility to participate in our share based long term incentive program. Benefits offered include a retirement savings plan, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage in accordance with the terms and conditions of the applicable plans. Salary range does not apply to the Tampa, FL location.

Relocation assistance may be available based on business needs and/or eligibility.

Sunshine Act

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

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