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RayzeBio Safety MD Senior Director

$306.81k - $371.79k

Bristol Myers Squibb

RayzeBio seeks a Safety MD Senior Director to lead medical safety and pharmacovigilance for radiopharmaceutical oncology programs. The role encompasses clinical safety oversight, regulatory compliance, risk management, and cross-functional collaboration across development and post-marketing activities.

Responsibilities

  • Lead global pharmacovigilance strategy, signal detection, and FDA/EMA regulatory compliance
  • Establish safety governance structures, SOPs, and continuous improvement processes
  • Direct safety evaluation and benefit-risk assessments for clinical and post-marketing products
  • Represent Safety Science in regulatory submissions, health authority interactions, and inspections
  • Mentor cross-functional colleagues and direct reports on pharmacovigilance practices

Requirements

  • MD or equivalent medical degree
  • 10+ years pharmacovigilance, safety science, or pharmaceutical industry experience
  • Knowledge of FDA, EMA, and ICH global pharmacovigilance regulations
  • Expertise in signal detection, risk management, and benefit-risk assessment
  • Experience interacting with regulatory authorities and scientific advisory bodies
  • Strong leadership and cross-functional collaboration skills

Compensation: $306,814 - $371,787 base

Vacancy posted a month ago
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