Director, Safety Risk Lead (MD)

Role Summary

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 Worldwide Safety (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 that are assigned
• 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‚Äôs 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‚Äôs business plan
• Represents SSRM on due diligence activities; coaches others in due diligences to support Pfizer‚Äôs 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‚Äôs 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.

Qualifications

• Medical Degree (MD, DO) or equivalent required
• 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 and/or drug development
• Disease area-specific knowledge in Oncology preferred
• Thorough understanding of safety risk management internal and external environment, including applicable regulations and guidances
• Comprehensive 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‚Äô areas of expertise and engages them effectively to achieve team objectives
• Demonstrated leadership in day-to-day activities, including strong interpersonal and collaborative skills

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

Education

• Medical Degree (MD, DO) or equivalent required

Additional Requirements

• Work Location Assignment: This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week.