Director, Digitized Adverse Event Processing & Device Vigilance

Bristol Myers Squibb

Madison, NJ, US
Base: $217,520 - $263,577; bonus/equity: + incenti...
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Director-level leadership in pharmacovigilance
Expertise in icsr and medical device reporting (mdr)
Implementation of ai, nlp, rpa, and llm tools
** Bristol Myers Squibb is seeking a Director for Digitized Adverse Event Processing & Device Vigilance, responsible for leading the transformation of pharmacovigilance processes using AI and digital technologies. The role emphasizes compliance with global regulatory standards and managing a diverse, globally distributed team. **

Job Summary

  • This senior leadership role is accountable for the end-to-end strategy and implementation of digitized adverse event case processing workflows using artificial intelligence and automation.
  • The position requires ensuring full compliance with global regulatory frameworks including 21 CFR Part 803, EU MDR, and ICH E2B(R3) standards for both drug and device safety reporting.
  • Candidates will lead a globally distributed team while driving a proactive, data-led pharmacovigilance model that integrates human-in-the-loop oversight for all AI-assisted decisions.

Matching Summary

Match Score: 75

** Bristol Myers Squibb is seeking a Director for Digitized Adverse Event Processing & Device Vigilance, responsible for leading the transformation of pharmacovigilance processes using AI and digital technologies. The role emphasizes compliance with global regulatory standards and managing a diverse, globally distributed team. **

Salary

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

Skills & Requirements

Must-have

  • Director-level leadership in Pharmacovigilance
  • Expertise in ICSR and Medical Device Reporting (MDR)
  • Implementation of AI, NLP, RPA, and LLM tools
  • Knowledge of 21 CFR Part 803 and EU MDR regulations
  • Experience with Oracle Argus or Veeva Vault Safety systems
  • Management of globally distributed teams across US, UK, India

Nice-to-have

  • Background in Digital Health or Data Science
  • Experience with Large Language Model governance frameworks
  • Familiarity with emerging AI pharmacovigilance strategies
  • Track record of vendor and CRO management
  • Engagement with industry forums like DIA or PhUSE

Key Requirements

  • Minimum 10+ years of experience in Pharmacovigilance or Drug Safety
  • At least 3-5 years at Director or equivalent senior leadership level
  • Minimum 7 years of hands-on ICSR case processing experience
  • Bachelor's degree in Life Sciences, Pharmacy, Medicine, or related field
  • Advanced degree (Master's, PharmD, MD, or PhD) preferred

Work Rights

Not specified

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