Risk Management Product Lead

1 week ago

WaltononThames, Surrey, United Kingdom Russell Tobin Full time

Position Purpose

  • 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 RM CoE.
  • Partners with the RAM 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.

Primary Responsibilities

  • In collaboration with RAM Head, develops/evolves/implements best practices in risk management planning, including risk communication, risk minimization and in benefit/risk assessment methodologies.
  • 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.
  • With oversight, 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.
  • Supports 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.
  • 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 (i.e., preferred education, experience, attributes)

  • Advanced degree preferred (Pharm.D, or Ph.D, or equivalents).
  • Senior Manager RMPL - Minimum 5 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance but with a clear focus on drug safety risk management.
  • Director RMPL - Minimum 10 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 the management of performance metrics.
  • Significant knowledge of organization processes and matrix-based decision-making is required.
  • Project management certification (PMP) and Six Sigma Certification are preferred.

Seniority level: Director

Employment type: Contract

Job function: Product Management

Industries: Pharmaceutical Manufacturing

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