Director, Safety Risk Lead (MD)

Role Summary

Director, Safety Risk Lead (MD) – This role requires experienced medical safety leadership to ensure robust benefit-risk understanding across Pfizer’s portfolio and advocate for patient safety throughout a product’s lifecycle. The Safety Surveillance & Risk Management (SSRM) Safety Risk Lead oversees global medical safety management, proactive signal detection and evaluation, and risk minimization to keep Pfizer products safe for patients.

Responsibilities

• Acts as a Safety point of contact for the Asset Teams and chairs the Risk Management Committees (RMCs), ensuring unified communication on safety matters for Worldwide Safety (WWS)
• Chairs RMCs and Core Working Groups for assigned products with minimal oversight
• Represents Pfizer WWS at internal governance and external regulatory or partner forums as appropriate
• Evaluates safety data from various sources, identifies and analyzes safety signals, and presents medical evaluations and benefit-risk assessments
• Provides disease-area specific pharmacovigilance expertise across assigned products
• Prepares independent action plans to address risk and benefit-risk issues, often requiring cross-functional collaboration
• Reviews and approves safety documents related to the benefit-risk profile of Pfizer‚Äôs products
• Ensures consistency of safety risk messaging across indications/BUs; participates in due diligence and coaches others
• 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 initiatives
• Supports inspection readiness with data provision to project managers for metrics and tracking
• Develops a culture of courage, excellence, equity and joy; provides regular communications, coaching, and mentoring
• Makes decisions based on clinical experience and assesses suitability of biopharmaceutical products in various health systems

Technical Skill Requirements

• Understanding of aggregate safety data, signal assessment methodology, and ability to perform benefit-risk assessments
• Ability to perform safety data review, assessment, signal identification, risk identification, and risk management
• Understanding of the scientific basis for therapies and drug-induced diseases
• Ability to lead cross-functional teams in a matrixed environment with minimal oversight
• Strong scientific and medical knowledge, including fluency in medical literature
• Ability to integrate data to support benefit/risk decision-making
• Understanding of statistics and analytical tools
• Knowledge of global safety/regulatory issues as they relate to development
• Effective verbal and written communication skills

Qualifications

• Medical Degree (MD, DO) or equivalent required
• 4+ years' experience including medical, scientific, pharmacovigilance or drug development roles
• Disease area-specific knowledge in Oncology preferred
• Thorough understanding of safety risk management, regulations, and guidances
• Comprehensive knowledge of drug development and post-marketing safety context
• Ability to influence internal and external stakeholders
• Ability to act independently and engage colleagues to achieve objectives
• Demonstrated leadership and collaborative skills

Education

• Medical Degree (MD, DO) or equivalent required