Jobs · Management · New Jersey

Director, Digitized Case Processing & Digital Adverse Event Interfaces

Bristol Myers Squibb EU Policy · Princeton, NJ · 5 days ago
HybridManagement$218k–$264k/yrFull-time

The Role

The purpose of this role is to ensure consistent global leadership for key R&D Quality processes within WWPS. This role focuses on all aspects of individual case safety reporting (ICSR) processes.

This role includes:

  • Leading the AI-powered transformation of adverse event intake
  • Owning the interfaces that connect BMS's safety ecosystem
  • Reinventing how BMS screens medical literature
  • Building and leading a world-class global team
  • Turning data into decisions

Qualifications

We're looking for a Director of Digitized Case Processing & Digital Adverse Event Interfaces - a leader who sits comfortably at the crossroads of pharmacovigilance science, cutting-edge technology, global regulation, and people leadership.

You'll need 10+ years in Pharmacovigilance or Drug Safety, including at least 3–5 years at Director level, and a minimum of 7 years of hands-on experience in ICSR data acquisition, case intake, or processing in pharma, biotech, or CRO environments.

Experience deploying AI, NLP, OCR, or RPA in a GxP-regulated environment, and a proven track record building AE data interfaces with internal and external partners are preferred.

Deep knowledge of ICH E2B(R3) across at least two major ICH regions, and familiarity with ARIS Global LifeSphere, Oracle Argus, or Veeva Vault Safety are beneficial.

What You'll Actually Be Doing

Leading the AI-powered transformation of adverse event intake

Owning the interfaces that connect BMS's safety ecosystem

Reinventing how BMS screens medical literature

Building and leading a world-class global team

Turning data into decisions

What You'll Bring To The Table

You'll need 10+ years in Pharmacovigilance or Drug Safety, including at least 3–5 years at Director level, and a minimum of 7 years of hands-on experience in ICSR data acquisition, case intake, or processing in pharma, biotech, or CRO environments.

Your ability to take a digital transformation vision and make it real — translating ambiguous future-state thinking into clear, actionable roadmaps that get delivered is a must-have.

You're equally at home in a regulatory conversation about ICH E2B(R3) compliance and a technical deep-dive on AI/NLP classifier performance.

You've been in the room during FDA, EMA, MHRA, and PMDA inspections — and you know what inspection-readiness really requires.

Benefits

Benefit offerings include:

  • Health Coverage
  • Wellbeing Support
  • Financial Well-being and Protection
  • Work-life Benefits

For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Similar jobs