Director, Safety Risk Lead

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 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
• Chairs RMCs and Core Working Groups for his/her assigned products with minimal 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 appropriate
• Evaluates safety data of any source with minimal 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
• Prepares action plans independently to address risk and benefit-risk issues, often requiring cross-functional activity to address safety issues and risk minimization plans
• Reviews and approves 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; coaches others in due diligences to support Pfizer’s business plan
• Represents SSRM on 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 the team as required.

Director Safety Risk Lead (MD Role):

• 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.

Technical Skill Requirements:

• 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 and lead through example, commitment and enthusiasm in a matrixed environment with minimal oversight
• Strong scientific and medical knowledge, including fluency in the medical literature
• Ability to integrate data to support benefit/risk decision-making
• Understanding of statistics and analytical tools
• Knowledge of global safety/regulatory issues and concerns as they relate to the business or clinical research-based compound development

Qualifications

• Required MD degree with min 4+ 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.