Director, Safety Risk Lead

Responsibilities:
- Provide global medical safety leadership for Pfizer products; advocate for patient safety across the product lifecycle.
- Oversee and perform proactive safety surveillance and risk management, including safety signal detection/evaluation, risk assessment, and safety risk minimization.
- Partner with cross-functional teams in benefit-risk management (Regulatory, Quality, Clinical, Medical, Corporate Audit, etc.) to enable one medical voice.
- Act as safety point of contact for Asset Teams; chair Risk Management Committees (RMCs) and Core Working Groups for assigned products.
- Evaluate safety data from any source; identify/analyze safety signals and present medical evaluations and benefit-risk assessments to appropriate forums.
- Provide disease-area specific pharmacovigilance expertise and apply it to assigned business unit products.
- Develop independent action plans to address safety and benefit-risk issues, often requiring cross-functional collaboration.
- Review and approve safety documents, including those related to product benefit-risk (B-R) profiles.
- Ensure consistent safety risk messaging across indications/business units; represent SSRM on due diligence and coach others to support the business plan.
- Identify opportunities for standards and consistency in safety surveillance and risk management processes.
- Innovate and implement novel approaches to safety surveillance and risk management; support continuous improvement and Safety Sciences Research & Communications.
- Support inspection readiness by providing data for project managers/metrics/activity tracking.
- Support team culture through regular communications, coaching, and mentoring.

Director Safety Risk Lead (MD Role):
- Make decisions based on clinical experience.
- Assess suitability of biopharmaceutical products in typical physician practice across varied health systems and care settings.

Qualifications:
- Required: MD degree with 4+ years’ experience including medical (patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification) and/or scientific and/or pharmacovigilance/drug development.
- Therapeutic focus may include Internal Medicine, Rare Disease, and/or Inflammation and Immunology.
- Thorough understanding of safety risk management, internal/external environment, and applicable regulations/guidance.
- Comprehensive knowledge of drug development process and post-marketing safety lifecycle.
- Ability to influence internal and external stakeholders; act independently while recognizing and engaging other experts.
- Demonstrated leadership in day-to-day activities; strong interpersonal and collaborative skills.
- Effective verbal and written communication skills.

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, clinical safety signal identification, and risk identification/risk management.
- Understanding of scientific basis for therapies and drug-induced diseases.
- Ability to lead cross-functional teams in a matrix environment with minimal oversight.
- Strong scientific/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 in clinical research-based compound development.