Director, Safety Risk Lead (MD)

Role Summary

Director, Safety Risk Lead (MD) at Pfizer. Accountable for global medical safety management of Pfizer products, leading proactive signal detection, evaluation, and risk minimization to ensure patient safety across the product lifecycle. Provides organizational leadership within SSRM and Pfizer, coordinating with Regulatory, Quality, Clinical, Medical, and other functions to enable one medical voice.

Responsibilities

• Acts as a Safety point of contact for Asset Teams and chairs the Risk Management Committees (RMCs), ensuring unified communication on safety matters for WWS
• Chairs RMCs and Core Working Groups for assigned products with minimal oversight
• Represents Pfizer WWS at internal governance and external forums as appropriate
• Evaluates safety data from various sources, identifies and analyzes safety signals, and presents medical evaluation of safety signals and benefit-risk assessments
• Provides disease-area specific pharmacovigilance expertise and applies this to products
• Prepares action plans to address risk and benefit-risk issues, often requiring cross-functional collaboration
• Reviews and approves safety documents pertaining to the benefit-risk profile of products
• Ensures consistency of safety risk messaging across indications/BUs; represents SSRM in due diligence and coaches others in due diligences
• Identifies opportunities for consistency and standards in safety surveillance and risk management processes
• Innovates and implements novel approaches to safety surveillance and risk management; engages in continuous improvement, Safety Sciences Research & Communications
• Engages in inspection readiness support and provides data for metrics and tracking
• Develops team culture with regular communications, coaching, and mentoring

Qualifications

• MD degree with minimum 4+ years' experience in medical, scientific, pharmacovigilance, or drug development
• Disease area knowledge in endocrinology, obesity, and metabolism
• Thorough understanding of safety risk management, regulations, and guidance
• Comprehensive knowledge of the drug development process and post-marketing experience
• Ability to influence internal and external stakeholders and work independently
• Demonstrated leadership, collaboration, and coaching abilities
• Strong communication skills, both verbal and written
• Understanding of aggregate safety data, signal assessment, benefit-risk decision-making, statistics, and analytical tools
• Knowledge of global safety/regulatory issues related to drug development

Skills

• Understanding of aggregate safety data and signal assessment methodology
• Safety data review and risk management across cross-functional teams
• Scientific basis for therapies and drug-induced diseases
• Lead cross-functional teams in a matrixed environment
• Fluency in medical literature; data integration for benefit/risk decisions
• Analytical skills and knowledge of statistics; global safety/regulatory awareness

Education

• MD degree (or equivalent) with relevant medical and/or pharmacovigilance experience

Additional Requirements

• Relocation support available
• Hybrid work location requiring on-site presence ~2.5 days per week