Director, Safety Risk Lead; MD

• United States - Pennsylvania - Collegeville
• United States - New York - New York City

We’re in relentless pursuit of breakthroughs that change patients’ lives. We innovate every day to make the world a healthier place.

To fully realize Pfizer’s purpose – Breakthroughs that change patients’ lives – we have established a clear set of expectations regarding “what” we need to achieve for patients and “how” we will go about achieving those goals.

Pfizer Research & Development serves as the beating heart of Pfizer's trailblazing product pipeline, the essence of our mission to bring life‑changing medicines to the world.

Pfizer offers competitive compensation and benefits programs designed to meet the diverse needs of our colleagues.

Position Purpose

As an experienced medical safety professional, the role requires exercising the highest quality of medical judgment to inform a robust understanding of the benefit‑risk profile across Pfizer’s portfolio and to advocate for patient safety from first‑in‑human and throughout a product’s lifecycle. The SSRM Safety Risk Lead is accountable for the global medical safety management of Pfizer products, performing proactive signal detection and evaluation, risk assessment/minimization to ensure Pfizer products are safe for patients.

• 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 WWS.
• Chairs RMCs and Core Working Groups for assigned products with minimal oversight.
• Represents Pfizer WWS at internal governance and business unit disease area leadership teams and external forums such as regulatory authorities and business partners.
• 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 appropriate forums.
• Provides disease‑area specific pharmacovigilance expertise and applies this to various business unit products.
• Prepares action plans independently to address risk and benefit‑risk issues, often involving cross‑functional activity.
• Reviews and approves safety documents including those pertaining to the B‑R profile of Pfizer’s products.
• Ensures consistency of safety risk messaging for a particular product or class of products across multiple indications/BUs.
• 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’s portfolio of products: engages in continuous improvement initiatives, Safety Sciences Research & Communications activities, including methodological improvements.
• Engages in inspection readiness support, providing 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.

• Makes decisions based on clinical experience.
• Assesses the suitability of biopharmaceutical products in typical physician practice within various health systems, hospitals, and non‑hospital patient care facilities.

• 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, 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.

• MD degree with a minimum of 4+ years of experience in medical…