Director, Safety Risk Lead; MD

Position Purpose

As an experienced medical safety professional, the role requires one to exercise 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 and performs proactive signal detection and evaluation, and risk assessment/minimization to ensure Pfizer products are safe for patients.

He/she will provide organizational leadership within SSRM and within Pfizer, including:

• Oversees and performs proactive safety surveillance and risk management to effect product safety signal detection & evaluation, risk assessment and safety risk minimization
• Works with other Pfizer functions engaged in benefit‑risk management (Regulatory, Quality, Clinical, Medical, Corporate Audit, etc) to enable one medical voice
• Articulates clear and informed medical judgement to enable sound business decisions and to enable productive engagement with health authorities.

• Acts as a Safety point of contact for the Asset Teams and chairs the Risk Management Committees (RMCs), ensuring a unified communication on safety matters for WWS
• Chairs RMCs and Core Working Groups for his/her assigned products with minimal oversight
• Represents Pfizer WWS at internal and external forums as appropriate
• 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 the appropriate forums
• Provides disease‑area specific pharmacovigilance expertise and applies this to various business unit products assigned to him/her
• Prepares action plans independently to address risk and benefit‑risk issues, often requiring cross‑functional activity to address safety issues and risk minimization plans
• 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. Represents SSRM on due diligence activities; coaches others in due diligences to support Pfizer’s business plan
• 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 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 regular communications, coaching, and mentoring of the team as required.

• Makes decisions based on clinical experience
• Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital 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 and 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 minimum 4+ years’ experience in medical (patient care, clinical trial…