Director, Digitized Case Processing & Digital Adverse Event Interfaces
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/.