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Director, Safety Risk Lead (MD)

Pfizer
Full-time
Remote friendly (Pennsylvania, United States)
United States
$219,800 - $366,400 USD yearly
Medical Affairs

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Role Summary

Director, Safety Risk Lead (MD) for Pfizer. Oversees global medical safety management, proactive signal detection and evaluation, and risk minimization to ensure product safety across the lifecycle. Provides organizational leadership within SSRM and Pfizer to enable one medical voice and effective benefit-risk management.

Responsibilities

  • Acts as a Safety point of contact for Asset Teams and chairs Risk Management Committees, ensuring unified safety communication for WWS
  • Chairs RMCs and Core Working Groups for assigned products with minimal oversight
  • Represents Pfizer WWS at internal 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
  • Provides disease-area pharmacovigilance expertise and applies to various products
  • Prepares action plans to address risk and benefit-risk issues, often requiring cross-functional activity
  • Reviews and approves safety documents pertaining to the benefit-risk profile
  • Ensures consistency of safety risk messaging across indications/BUs; participates in due diligence and coaches others
  • Identifies opportunities for consistency and standards in safety surveillance and risk management
  • Innovates and implements novel approaches to safety surveillance and risk management; engages in continuous improvement and Safety Sciences activities
  • Supports inspection readiness with data provision for metrics and tracking
  • Develops team culture with regular communications, coaching, and mentoring

Qualifications

  • MD degree with a minimum of 4+ years of experience in medical practice, clinical trials, academic medicine, or pharmacovigilance/drug development
  • Disease area knowledge in endocrinology, obesity, and metabolism
  • Thorough understanding of safety risk management and regulatory guidance
  • Comprehensive knowledge of drug development and post-marketing safety
  • Ability to influence stakeholders and act independently while leveraging team expertise
  • Demonstrated leadership, collaboration, and coaching abilities
  • Strong verbal and written communication skills
  • Knowledge of aggregate safety data, signal assessment, benefit-risk integration, statistics, and global safety/regulatory issues

Skills

  • Clinical safety data review and risk management
  • Cross-functional leadership in a matrixed environment
  • Evidence-based medical judgment and decision-making
  • Fluency in medical literature and data integration for benefit/risk decisions

Education

  • MD degree; board certification or equivalent experience in relevant field

Additional Requirements

  • Hybrid work arrangement requiring on-site presence ~2.5 days per week within commuting distance
  • Relocation support available
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