Manager, Global Patient Safety Scientist Job at Regeneron, Warren, MA

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  • Regeneron
  • Warren, MA

Job Description

Regeneron seeks a Manager, Global Patient Safety Scientist to lead safety strategy and analysis for molecules in clinical development and post-marketing phases. The role involves signal detection, safety evaluation, and preparation of regulatory documents to support benefit-risk assessment across a portfolio of compounds.

Responsibilities

  • Conduct signal detection activities aligned with approved safety surveillance plans
  • Evaluate identified signals and author comprehensive safety evaluation reports
  • Prepare and review safety documents including DSUR, PSUR, RMP, and health authority responses
  • Present findings at Signal Management Team meetings and participate in clinical study team discussions
  • Contribute to risk management activities and cross-functional oversight committees

Requirements

  • Master's degree, PharmD, or PhD
  • Minimum 5+ years of risk management or clinical experience in pharmaceutical or biotech industry
  • Knowledge of FDA, EU, and ICH guidelines for pharmacovigilance in clinical and post-marketing settings
  • Proficiency with safety database systems for medical case review and queries
  • Advanced data manipulation and visualization skills using Excel and pivot tables
  • Strong verbal and written communication of complex safety findings
  • Self-directed with ability to prioritize and meet multiple deliverables

Compensation: $114,800–$187,400 base annually

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