Pharmacovigilance Risk Management Product Lead, Sr. Manager

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.

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.

ROLE 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.

BASIC 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.

PREFERRED QUALIFICATIONS:

• Advanced degree strongly preferred (Pharm.D, or Ph.D, or equivalents).

TECHNICAL SKILLS REQUIREMENTS:

• High level analytical skills - Detail oriented, independent, and manage processes to both establish timelines and ensure timelines are met. Excellent organizational skills.

• Strategic Thinking – Demonstrated ability to analyze, frame, and communicate complex issues, including writing and presentation proficiency.

• Clinical, Regulatory and Safety Expertise - Demonstrated 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 - Demonstrated ability to scientifically evaluate and document review and analysis of data.

• Organizational Development – Knowledge of organizational development principles and demonstrated success in developing and implementing organizational development strategies.

• Project and Process Management & Meeting Established Deadlines – Demonstrated 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 presentations, etc., as well as department systems.

• Skills in matrix partnerships to affect inclusive and collaborative working relationships with global Safety colleagues, including engaging SSRM Group Heads, Epidemiology Leads and other colleagues supplying sources of safety information. Actively engage global Regulatory, Clinical, Nonclincial, Medical, and relevant individuals from in-country teams as needed.

ADDITIONAL DETAILS

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

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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