Director, Safety Risk Lead (MD)

Role Summary

Director, Safety Risk Lead (MD) at Pfizer. Accountable for global medical safety management of Pfizer products, performing proactive signal detection and evaluation, and risk assessment/minimization to ensure product safety. Provides organizational leadership within Safety Surveillance & Risk Management (SSRM) and Pfizer, overseeing safety surveillance, risk management, and benefit-risk communications.

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 Worldwide Safety (WWS).
• Chairs RMCs and Core Working Groups for assigned products with minimal oversight.
• Represents Pfizer WWS at internal governance, disease area leadership teams, and external forums as appropriate.
• Evaluates safety data from any source, identifies and analyzes safety signals, and presents medical evaluation of safety signals and benefit-risk assessments to appropriate forums.
• Provides disease-area specific pharmacovigilance expertise across assigned products.
• Prepares action plans to address risk and benefit-risk issues, often requiring cross-functional activity for safety issues and risk minimization plans.
• Reviews and approves safety documents pertaining to the benefit-risk profile of Pfizer‚Äôs 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 initiatives and Safety Sciences Research & Communications activities.
• 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 communications, coaching, and mentoring.
• Makes decisions based on clinical experience and assesses the suitability of biopharmaceutical products in various health systems and facilities.

Technical Skill Requirements

• Understanding of aggregate safety data, signal assessment, and ability to perform benefit-risk assessments.
• Ability to perform safety data review/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 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 related to development and post-marketing.
• Effective verbal and written communication skills.

Qualifications

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

Education

• Medical Degree (MD, DO) or equivalent required.