Safety Risk Lead (SRL) Senior Manager (MD)

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.
   

Professional Experience & Educational Requirements

• MD (physician)

  Minimum Years of  Experience*: 2 years

  *Minimum Years of 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 and/or drug development

Additional Qualifications

• Disease area-specific knowledge preferred

• Awareness of safety risk management internal and external environment, including applicable regulations and guidances

• Knowledge of drug development process and post-marketing experience, including an 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

• Demonstrated leadership in day-to-day activities, including strong interpersonal and collaborative skills
   

Technical Skills

• 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

• Effective verbal and written communication skills in English.

 
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