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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Purpose
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.
Digital Transformation Strategy
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Equal Employment Opportunity
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms - allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.
Medical
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