ROLE SUMMARY 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 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: • 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 Affairs, Quality, CMO, 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. ROLE 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 safety • Chairs RMCs and Core Working Groups for his/her assigned products with oversight • Represents 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 Manager • Evaluates 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 forums • Provides disease area specific pharmacovigilance expertise, and applies this to various business unit products assigned to him/her • Assists 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 plans • Prepares and contributes to written safety assessments and benefit-risk evaluations • Reviews and approves, as appropriate, safety documents including those pertaining to the B-R profile of Pfizer’s products • Ensures consistency of safety risk messaging for a particular product or class of products, across multiple indications/BUs. Represents SSRM on due diligence activities • 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 the team as required. • Makes decisions based on clinical experience • Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities.