Senior Manager- Risk Management Product Lead
Senior Manager- Risk Management Product Lead
申请 locations: United States - New York - New York City; United Kingdom - Walton Oaks; Ireland - Dublin - Grange Castle; Poland - Warsaw; Italy - Milan
Time type: 全职
Posted on: 发布于 2 天前
Job requisition id: 4935493
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 creating frameworks to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise, or investigating data gaps, our mission is to empower healthcare decisions regarding the safe and appropriate use of medicines for patients.
Position Purpose
* Provide strategic expertise to product teams and drive Risk Management activities within RMPs across business units to embed a culture of innovative and efficient risk management strategies to enhance patient safety.
* Collaborate on developing the next generation Risk Management Center of Excellence (RMCoE).
* Partner with the RMCoE Head to establish and maintain processes and changes.
* Lead in managing and building risk management knowledge within the organization.
* Provide expertise on RMP requirements and implementation for both pre-marketed and post-marketed drug products.
* Recommend risk mitigation options for drug safety issues, considering benefit-risk profiles and internal/external approaches.
* Review RMP assessment reports for necessary modifications.
* Develop and implement best practices in risk management planning, communication, minimization, and benefit/risk assessment methodologies in collaboration with RMCoE.
Job Responsibilities
* Develop and evolve risk management practices, including communication and minimization strategies.
* Support Safety Surveillance & Risk Management with strategic guidance considering regulatory requirements and product profiles.
* Serve as the key interface between RAM and Business Units for oversight of RMP implementation and tracking.
* Lead PRMS meetings, prepare agendas and minutes, and ensure action items are completed.
* Manage supplier performance and support daily communications.
* Report on RMP milestones and performance via dashboards.
* Maintain project planning documentation and update related records.
* Provide risk management education internally and externally.
* Participate in audits and inspections, preparing responses and maintaining inspection readiness.
Qualifications
* B.S. or M.S. in health science; advanced degrees (Pharm.D, Ph.D.) preferred.
* Minimum 5 years in pharma with focus on drug safety risk management.
* Knowledge of global safety regulations and experience in RMP development.
* Strong analytical, communication, organizational, and project management skills.
* Familiarity with performance metrics and organizational processes.
* Project management (PMP) and Six Sigma certifications preferred.
Technical Skill Requirements
* High-level analytical skills, detail orientation, and organizational skills.
* Strategic thinking and proficiency in writing and presentations.
* Knowledge of clinical research, safety, and regulatory requirements.
* Technical expertise in safety and risk management concepts.
* Ability to evaluate and document data scientifically.
* Skills in organizational development and managing multiple projects.
* Proficiency in MS Office and departmental systems.
Work Location: Hybrid
Additional locations: NY, Ireland, Italy, UK
The annual salary ranges from $112,700 to $187,800, with bonus and long-term incentives. Benefits include 401(k), paid leave, health coverage, and more. Relocation assistance may be available.
Additional Information
Pfizer complies with transparency laws, including the Sunshine Act, and is committed to equal opportunity employment. This position requires U.S. work authorization.
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