Safety Risk Lead, Sr. Director

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) Safety Risk Lead is accountable for the global medical safety management of Pfizer products and performs proactive signal detection and evaluation, and risk assessment/minimization to ensure Pfizer products are safe for patients. 

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

• Oversees and performs proactive safety surveillance and risk management to effect product safety signal detection & evaluation, risk assessment and safety risk minimization
• Works with other Pfizer functions engaged in benefit-risk management (Regulatory, Quality, Clinical, Medical, Corporate Audit, etc) to enable one medical voice
• Articulates clear and informed medical judgement to enable sound business decisions and to enable productive engagement with health authorities.

Primary Responsibilities

• Acts as a Safety point of contact for the Asset Teams and chairs the Risk Management Committees (RMCs), ensuring a unified communication on safety matters for WWS Conducts and chairs Core Working Groups for his/her assigned products
• Represents Pfizer WWS at senior internal (e.g. governance and business unit disease area leadership teams) and external forums  (e.g. regulatory authority and business partner interactions)
• Independently evaluates safety data of any source, identifies and analyzes complex safety signals, and presents medical evaluation of safety signals and benefit-risk assessments to the appropriate forums
• Provides disease-area specific pharmacovigilance expertise and applies this to various business unit products assigned to him/her.
• Prepares action plans to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues and risk minimization plans
• Reviews and approves critical safety documents regarding the B-R profile of Pfizer’s products
• Prepares and contributes to written safety assessments and benefit-risk evaluations
• Ensures consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs
• Represents SSRM on complex due diligence activities; coaches others in due diligences to support Pfizer’s business plan
• 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 Pfizer’s portfolio of products: engages in continuous improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements
• Engages in inspection readiness support including provision of data to project managers for metrics and activity tracking
• Develops a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of colleagues as required.

Qualifications

• Master's degree with 10+ years' OR PhD/PharmD with 7+ years' experience to include medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or drug development.
• Disease area - specific knowledge: background and experience in endocrinology, obesity, and metabolism

Preferred Additional Qualifications

• 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 independently, seeking guidance as appropriate; recognizes other colleagues’ areas of expertise and engages them effectively to achieve team objectives
• Strong understanding of aggregate safety data and signal assessment methodology, and ability to perform benefit-risk assessments
• Ability to perform safety data review, safety data assessment, Clinical safety signal identification, risk identification and risk management
• Understanding of the scientific basis for therapies and drug-induced diseases
• Ability to lead a cross functional team through example, commitment and enthusiasm in a matrixed environment
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