Principal Scientist, Drug Safety Job at Merck, Upper Gwynedd, PA

  • Merck
  • Upper Gwynedd, PA

Job Description

Merck seeks a physician leader to direct clinical risk management and pharmacovigilance for investigational and marketed products. The role involves developing safety strategies, chairing risk management teams, and collaborating across functions to ensure robust benefit-risk evaluation throughout the product lifecycle.

Responsibilities

  • Chair Risk Management and Safety Team for assigned products and participate on development teams
  • Evaluate safety data from trials, literature, and post-approval use; lead surveillance activities
  • Develop and maintain risk management and pharmacovigilance plans for assigned products
  • Provide medical oversight for regulatory documentation including Risk Management Plans and safety submissions
  • Collaborate with clinical development, epidemiology, regulatory, biostatistics, and manufacturing teams

Requirements

  • M.D., D.O., or equivalent medical degree
  • Minimum 3 years clinical experience post-training or relevant clinical background
  • Demonstrated leadership in clinical safety, pharmacovigilance, or drug development
  • Strong medical judgment and ability to assess complex safety information
  • Excellent communication, writing, and analytical skills
  • Ability to collaborate effectively across matrixed organizations
  • Board certification preferred

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