Position Purpose

Performs proactive safety surveillance and risk management to effect product safety signal detection & evaluation, risk assessment and safety risk minimizationWorks with other Pfizer functions engaged in benefit-risk management (Regulatory Affairs, Quality, CMO, Corporate Audit, etc) to enable one medical voiceArticulates clear and informed medical judgement to enable sound business decisions and to enable productive engagement with health authorities.

Primary Responsibilities

Act as a point of contact for Safety in the Asset Teams, ensuring a unified communication on safety matters and representing WWS position(s) on safetyChairs RMCs and Core Working Groups for his/her assigned products with oversightRepresents Pfizer WWS at internal (e.g. governance and business unit disease area leadership teams) and external forums  (e.g. regulatory authority and business partner interactions) as agreed with ManagerEvaluates safety data of any source with oversight, identifies and analyzes safety signals, and presents medical evaluation of safety signals and benefit-risk assessments to the appropriate forumsProvides disease area specific pharmacovigilance expertise, and applies this to various business unit products assigned to him/herAssists with preparation of basic action plans to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues and risk minimization plansPrepares and contributes to written safety assessments and benefit-risk evaluationsReviews and approves, as appropriate, safety documents including those pertaining to the B-R profile of Pfizer’s productsEnsures consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs. Represents SSRM on due diligence activitiesIdentifies opportunities for consistency and standards for safety surveillance and risk management processesInnovates, 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 improvementsEngages in inspection readiness support including provision of data to project managers for metrics and activity trackingDevelops a culture of courage, excellence, equity and joy within the team including regular communications, coaching, and mentoring of the team as required.

Technical Skill Requirements

Understanding of aggregate safety data and signal assessment methodology, and ability to perform benefit-risk assessmentsAbility to perform safety data review, safety data assessment, Clinical safety signal identification, risk identification and risk managementUnderstanding of the scientific basis for therapies and drug-induced diseasesAbility to lead a cross functional team and lead through example, commitment and enthusiasm in a matrixed environment with minimal oversightStrong scientific and medical knowledge, including fluency in the medical literatureAbility to integrate data to support benefit/risk decision-makingUnderstanding of statistics and analytical toolsKnowledge of global safety/regulatory issues and concerns as they relate to the business or clinical research-based compound developmentEffective verbal and written communication skills.  
Work Location Assignment: Hybrid

EEO (Equal Employment Opportunity) & Employment Eligibility 

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.

Medical

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