Director, Digitized Adverse Event Processing & Device Vigilance

Bristol Myers Squibb

Madison, NJ, US
Base: $217,520 - $263,577; bonus/equity: + incenti...
50% onsite
Director or equivalent senior leadership level
7+ years icsr case processing experience
Device safety reporting mdr obligations
Bristol Myers Squibb is seeking a Director for Digitized Adverse Event Processing & Device Vigilance, a senior leadership role focused on transforming pharmacovigilance processes using digital technologies. The position is responsible for developing strategies and overseeing compliance in adverse event reporting, while leading a global team across multiple locations

Job Summary

  • This senior leadership role is accountable for the end-to-end strategy and transformation of adverse event case processing using AI, NLP, and RPA technologies.
  • The position requires overseeing global Medical Device Reporting (MDR) obligations under 21 CFR Part 803 and EU MDR/IVDR frameworks while managing a distributed team.
  • Bristol Myers Squibb offers competitive compensation ranging from $217,520 to $263,577 along with comprehensive benefits including flexible time off and wellness programs.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking a Director for Digitized Adverse Event Processing & Device Vigilance, a senior leadership role focused on transforming pharmacovigilance processes using digital technologies. The position is responsible for developing strategies and overseeing compliance in adverse event reporting, while leading a global team across multiple locations.

Salary

Base: $217,520 - $263,577; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Health coverage, 401(k), paid time off, and wellbeing support

Skills & Requirements

Must-have

  • Director or equivalent senior leadership level
  • 7+ years ICSR case processing experience
  • Device safety reporting MDR obligations
  • AI/NLP/RPA implementation in GxP environment
  • Global team management across US UK India

Nice-to-have

  • Advanced degree in Life Sciences or Computer Science
  • Experience with Large Language Models (LLM)
  • Vendor and CRO management expertise
  • Knowledge of digital health regulatory policy
  • Community of Practice leadership experience

Key Requirements

  • Minimum 10+ years Pharmacovigilance experience
  • Bachelor's degree required; Master's/PhD preferred
  • Proven track record managing regulatory inspections
  • Experience with Oracle Argus or Veeva Vault Safety
  • Working knowledge of ICH E2B(R3) standards

Work Rights

Not specified

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