Safety Surveillance & Risk Management Disease Area Cluster Lead, MD

Position Purpose

As an experienced medical safety professional, the role requires one to exercise the highest quality of medical judgment to inform a robust understanding of the benefit-risk profile across Pfizer’s portfolio and to advocate for patient safety from first-in-human and throughout a product’s lifecycle. The Safety Surveillance & Risk Management (SSRM) Disease Area Cluster Lead is accountable for the global medical safety management of Pfizer products in his/her disease area. The SSRM DACL seeks innovative ways to continually improve our approach to signal detection, evaluation and management to ensure Pfizer products are safe for patients. 

He/she will provide organizational leadership within SSRM and within Pfizer, including:

• Managing one or more SSRM Disease Areas, including supervision of the Safety Risk Leads (SRLs) globally supporting the respective Disease Area(s)
• Overseeing and performing proactive safety surveillance and risk management to effect product safety signal detection & evaluation, risk assessment and safety risk minimization
• Working with other Pfizer functions engaged in benefit-risk management (Regulatory Affairs, Quality, CMO, Corporate Audit, etc) to enable one medical voice
• Articulating clear and informed medical judgement to enable sound business decisions and to enable productive engagement with health authorities
• Developing talent and leadership across SSRM

Primary Responsibilities 

The Disease Areas Cluster Lead:

• Is an integral participating member of the SSRM-LT. They may represent SSRM Unit Head in WWS management and operational matters, and may be a member of the Extended PVLT 
• Effectively communicates resource, timeline and other Disease Area and product issues as appropriate to the SSRM Unit Head
• Supports the role of the SRLs, acting as both a manager and individual contributor performing senior SRL responsibilities when needed which includes performing proactive safety surveillance and risk management/minimization of Pfizer’s portfolio of products
• Conducts proactive resource planning and manages flexible and dedicated resources across their Disease Area(s) to ensure appropriate surveillance of Pfizer’s portfolio of products
• Is responsible for the effective leadership of an engaged team of colleagues performing in an appropriate work environment, and for the related training and development, performance management, succession planning, and human resources processes, all while ensuring compliance with required regulations and practices
• Develops a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of the team as required
• Directly contributes to Safety Strategy activities, especially those defined by SOPs
  • Supports the SRLs with their responsibility of acting as a Safety point of contact to the Asset Teams and Chairs of the Risk Management Committees (RMCs), ensuring a unified communication on safety matters for WWS
  • Reviews and approves critical safety documents regarding the B-R Profile of Pfizer’s products
  • Represents Pfizer WWS at senior internal (e.g. governance and BU Disease Area Leadership teams) and external forums (e.g. FDA interactions)
  • Leverages focused expertise across BU segments and deployment to support due diligence in-licensing assessments
  • Identifies opportunities for consistency and standards for safety surveillance and risk management processes 
  • Innovates, champions and implements novel approaches to safety surveillance and risk management across disease areas, including  engagement in continuous improvement initiatives  
  • Provides active inspection readiness support, including provision of data for metrics and activity tracking.

Qualifications

• Medical degree and 5+ years of experience (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development

Additional Qualifications

• Managerial/supervisory experience
• Disease area-specific knowledge   
• Relevant knowledge of pharmaceutical company organizational structure, policies, and practices, as applicable to safety risk management
• Thorough understanding of safety risk management internal and external environment, including applicable regulations and guidances. 
• Comprehensive knowledge of drug development process and post-marketing experience, including and understanding of safety context across the drug lifecycle
• Ability to influence internal and external stakeholders  
• Ability to act inde