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

One bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.

Flexibility  

We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation!  

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.

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