Sr. Manager, Risk Management Product Lead

Role Summary

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.

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

• Bachelors degree and 6+ years of experience or Masters 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 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 matrix-based decision-making is required
• Project management certification (PMP) and Six Sigma Certification preferred

Skills

• High level analytical skills - Detail oriented, independent, and manage processes to both establish timelines and ensure timelines are met. Excellent organizational skills.
• Strategic Thinking – Ability to analyze, frame, and communicate complex issues, including writing and presentation proficiency.
• Clinical, Regulatory and Safety Expertise - Knowledge of clinical research processes, safety or regulatory requirements. Knowledge of Risk Management regulations and drug development process
• Technical Expertise – Applies technical and line knowledge of key concepts in own discipline and may act as a key technical resource within line.
• Scientific/Administrative Excellence - Ability to scientifically evaluate and document review and analysis of data.
• Organizational Development – Knowledge of organizational development principles and success in developing and implementing organizational development strategies.
• Project and Process Management & Meeting Established Deadlines – Ability to manage multiple complex projects and cross-functional processes and to meet established deadlines. Experience in budgetary management
• Computer applications - MS Word, Excel, PowerPoint, etc., as well as department systems.
• Matrix partnerships to foster inclusive and collaborative working relationships with global Safety colleagues, including engaging SSRM Group Heads, Epidemiology Leads and other colleagues supplying sources of safety information.

Additional Requirements

• Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.