Director, Digitized Case Processing & Digital Adverse Event Interfaces

Job Description

Position Summary

Director of Digitized Case Processing & Digital Adverse Event Interfaces. Lead AI‑powered transformation of adverse event intake, manage interfaces, lead global team, design KPI framework. Work at the intersection of pharmacovigilance science, technology, regulation and people leadership.

Key Responsibilities
  • Define and own the multi‑year digital intake roadmap, delivering automated, touchless AE case creation workflows inside a validated GxP framework.
  • Own all interfaces that bring adverse event data into and out of BMS, from Medical Information & Clinical Development to CROs, licensing partners, and regulatory portals such as FAERS, EudraVigilance, MHRA and PMDA.
  • Drive ICH E2B(R3) electronic exchange adoption and replace manual transmissions with validated, auditable data pipelines.
  • Lead the digital transformation of the Medical Literature Screening programme, leveraging AI/NLP across databases (PubMed, EMBASE, Cochrane, J‑Stage).
  • Build and lead a world‑class global team across the US, UK, Switzerland, India and Japan; cultivate a culture of psychological safety, scientific rigor and continuous improvement.
  • Design and own the KPI framework for touch‑less processing rates, intake cycle times, data completeness, literature screening accuracy and vendor SLA performance.
  • Use operational analytics and AI‑generated dashboards to identify bottlenecks and drive continuous improvement.
Qualifications
  • 10+ years in Pharmacovigilance or Drug Safety, including 3–5 years at Director level.
  • Minimum 7 years hands‑on experience in ICSR data acquisition, case intake or processing in pharma, biotech or CRO environments.
  • Proven ability to translate digital transformation vision into actionable roadmaps and deliver them.
  • Strong regulatory knowledge (ICH E2B(R3) compliance) and familiarity with FDA, EMA, MHRA, PMDA inspections.
  • Experience deploying AI, NLP, OCR or RPA in a GxP‑regulated environment.
  • Track record building AE data interfaces with internal and external partners.
  • Experience managing cross‑regional teams and exposure to AI governance in life sciences.
  • Knowledge of ARIS Global LifeSphere, Oracle Argus, or Veeva Vault Safety (preferred).
Benefits & Perks
  • Competitive benefits, services and programs to support work and personal life balance.
  • Flexibility in work location: hybrid model with at least 50% onsite for eligible roles.
  • EEO Statement: BMS is a Disability Confident employer. See our complete Equal Employment Opportunity statement at careers.bms.com/eeo-accessibility.
  • Support for reasonable workplace accommodations for people with disabilities.
Contact Information

Role: R1601779. For questions or to request accommodations, contact [email protected] or use careers.bms.com/eeo-accessibility for EEO information.

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Job Overview

ID:

2564950

Date Posted:

Posted 13 hours ago

Expiration Date:

09/08/2026

Location:

Uxbridge

Salary:

Competitive

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