Director, Risk Management Product Lead

Role Summary

Provide strategic expertise to product teams and drive the execution of Risk Management activities across business units to embed a culture of innovative and efficient risk management strategies to enhance patient safety. Develop and evolve methods and processes to advance the Risk Management Center of Excellence and ensure effective risk management for pre-marketed and post-marketed drug products.

Responsibilities

• In collaboration with the RMCoE Head, develop/evolve/implement best practices in risk management planning, including risk communication, risk minimization and in benefit/risk assessment methodologies.
• Support Safety Surveillance & Risk Management with strategic guidance for risk management planning, considering local regulatory requirements, best practices, and product-specific risk profiles; develop and implement RMP initiatives for Pfizer products.
• Serve as the key interface between RAM and the BU for oversight of RMP commitments and provide periodic updates on implementation status to the RMC.
• Lead PRMS with effective leadership and process management; create agendas, draft/finalize minutes, drive actions to completion, and manage meeting action items; ensure appropriate attendance and engagement.
• Manage supplier performance relative to SOW; support day-to-day supplier communications.
• Provide regular reporting on RMP milestones/performance via dashboards and KPIs; maintain project planning and execution documentation (charters, plans, progress reports, logs, deliverables).
• Update/maintain project documentation; provide risk management education to internal and external colleagues.
• Participate in audits/inspections; prepare responses and participate in inspection readiness; act as SME or BPO for a Safety SOP.
• Manage special projects and communications; provide guidance and coaching to less experienced RMPLs; train new RMPLs and assist with issue resolution.
• Recommend external safety KOL consultations, expert groups, and other external safety forums; drive standardization in Safety practices.
• Identify and evaluate issues and present strategies to meet or accelerate timelines; influence Safety, Regulatory, and Medical stakeholders at multiple levels.

Qualifications

• Required: Bachelor’s degree with 8+ years of experience, or Master’s degree with 7+ years, or Pharm.D/Ph.D or equivalents with 1+ years of industry experience; minimum 10 years of broad and progressive pharma experience in medical, clinical or pharmacovigilance with a focus on drug safety risk management; knowledge of global safety regulations and guidelines; demonstrated experience in global drug safety risk management planning and RMP generation; strong analytical, communication, negotiation, and organizational skills; familiarity with performance metrics and matrix-based decision-making; PMP and Six Sigma certification preferred.
• Preferred: Advanced degree (Pharm.D or Ph.D or equivalents).

Skills

• High-level analytical skills; detail-oriented; strong organizational abilities.
• Strategic thinking with ability to frame and communicate complex issues; writing and presentation proficiency.
• Clinical, regulatory and safety expertise; knowledge of risk management regulations and drug development processes.
• Technical expertise within the discipline; ability to act as a key technical resource.
• Scientific/administrative excellence in evaluating and documenting data; organizational development and program management capability; budgetary awareness.
• Proficiency with MS Word, Excel, PowerPoint; capability to engage in matrix partnerships across global Safety and related stakeholders.

Additional Requirements

• Work Location Assignment: Hybrid role; live within commuting distance and be on-site an average of 2.5 days per week or more as needed.