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Pfizer · 8 hours ago

Sr. Manager, Risk Management Product Lead

United States - Massachusetts - Cambridge

Full-time

Hybrid

Mid, Senior Level

$116K/yr - $188K/yr

5+ years exp

Pfizer is a leading pharmaceutical company seeking a Sr. Manager, Risk Management Product Lead to provide strategic expertise in risk management activities. The role involves collaborating with product teams to enhance patient safety through innovative risk management strategies and ensuring compliance with regulatory requirements.

BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine

No H1B

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

Qualification

Risk Management PlanningDrug Safety ExpertiseAnalytical SkillsProject Management CertificationGlobal Safety RegulationsInterpersonal SkillsOrganizational SkillsPerformance Metrics ManagementMatrix PartnershipsScientific EvaluationCommunication SkillsNegotiation SkillsTeam CollaborationDetail Oriented

Required

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

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