Director, Safety Risk Lead (MD)

Role Summary

Director, Safety Risk Lead (MD) at Pfizer. Role focuses on global medical safety management, proactive signal detection and risk minimization across Pfizer’s portfolio to ensure patient safety. Provides organizational leadership within Safety Science and Risk Management (SSRM) and across Pfizer, coordinating with regulatory, quality, clinical, medical, and other functions to enable a unified 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 World-Wide Safety (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 evaluations and benefit-risk assessments.
• Provides disease-area specific pharmacovigilance expertise to products assigned.
• Prepares action plans to address risk and benefit-risk issues, often requiring cross-functional collaboration for risk minimization plans.
• Reviews and approves safety documents related to the benefit-risk profile of Pfizer products.
• Ensures consistency of safety risk messaging across indications and business units; participates in due diligence and coaches others in due diligences.
• Identifies opportunities for standardization of safety surveillance and risk management processes; drives continuous improvement initiatives.
• Engages in inspection readiness and provides data to project managers for metrics and tracking.
• Develops team culture through communication, coaching, and mentoring.
• Makes decisions based on clinical experience and assesses suitability of biopharmaceutical products within various health systems.

Qualifications

• MD degree with at least 4 years of experience in medical care, clinical trials, academic medicine, specialty training, board certification, or related scientific/pharmacovigilance/drug development.
• Disease-area knowledge in endocrinology, obesity, and metabolism is required.
• Thorough understanding of safety risk management within regulatory guidance; broad understanding of drug development and post-marketing safety.
• Ability to influence internal and external stakeholders; independent work style with effective collaboration.
• Leadership experience, coaching abilities, and capability to oversee cross-functional teams in a matrixed environment.
• Strong scientific and medical knowledge; fluency in medical literature; ability to integrate data for benefit/risk decision-making.
• Understanding of statistics and analytical tools; knowledge of global safety/regulatory issues related to drug development.
• Effective verbal and written communication skills.

Skills

• Understanding of aggregate safety data, signal assessment, and benefit-risk evaluation.
• Safety data review and risk management capabilities; identification and management of clinical safety signals.
• Cross-functional leadership in a matrixed environment; ability to lead by example.
• Strong scientific and medical knowledge; data integration for decision-making.
• Knowledge of global safety/regulatory issues related to drug development and post-marketing.
• Communication skills for internal and external stakeholders.

Education

• MD degree (required); relevant advanced training or certification in pharmacovigilance or drug development is a plus.

Additional Requirements

• Relocation support available.
• Hybrid work arrangement: live within commuting distance and on-site ~2.5 days per week.