Director, Digitized Adverse Event Processing & Device Vigilance

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Position Summary

The Director, Digitized Case Processing & Device Vigilance is a senior leadership role accountable for the end-to-end strategy, design, implementation, and continuous improvement of digitized adverse event (AE) case processing workflows within BMS's global PV Operations & Systems function.

This role leads the transformation of ICSR and Medical Device Report Safety processing through artificial intelligence (AI), natural language processing (NLP), robotic process automation (RPA), and digital ingestion platforms while ensuring full compliance with applicable GxP standards and global device reporting (MDR) regulatory requirements. The Director will oversee a globally distributed team spanning the US, UK, and India within a matrix environment also including Japan, and will serve as the key interface between the Case Management function PS sub-functions and IT/Digital, Regulatory Affairs, Quality, and external vendors.

The role holder is accountable for driving BMS toward a proactive, data-led pharmacovigilance model in alignment with applicable global regulatory frameworks, while ensuring that device and combination product safety processing and reporting obligations are fulfilled.

Duties/Responsibilities

Digital Strategy & AI-Enabled Case Processing

• Develop and execute the multi-year digital transformation roadmap for ICSR case processing, aligned with the BMS enterprise AI strategy and PV Operations roadmap

• Lead implementation of AI, NLP, OCR, RPA, and Large Language Model (LLM)-assisted tools to enable automated ingestion, triage, and processing of adverse event data from structured and unstructured sources (e.g., EHRs, free-text narratives, digital health applications, social media, medical literature, and partner data transfers)

• Partner with BMS Digital & Technology (D&T) and external technology vendors to evaluate, validate, deploy and develop intelligent case processing platforms (e.g., ArisGlobal LifeSphere, IQVIA Vigilance Detect, Oracle Argus AI-augmented workflows) ensuring fit-for-purpose implementation

• Define and govern a human-in-the-loop (HITL) oversight framework ensuring all AI-assisted case decisions are subject to qualified medical/safety review, meeting applicable regulatory expectations and guidance on Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making

• Contribute to validation lifecycle of all AI/ML tools used within the ICSR processing workflow in accordance with 21 CFR Part 11, GxP computer systems validation (CSV), and emerging regulatory expectations

• Champion the adoption of ICH E2B(R3) digital submission standards across all BMS reporting pathways.

Device Reporting & MDR Oversight

• Accountable for BMS's global Medical Device Reporting (MDR) obligations under 21 CFR Part 803, ensuring timely (5-day and 30-day) eMDR submissions to the FDA for device-associated adverse events, malfunctions, and combination product safety issues

• Oversee compliance with EU MDR/IVDR device-related pharmacovigilance obligations and the integration of device malfunction data into ICSRs submitted to EudraVigilance under GVP Module VI using ICH E2B(R3) standards

• Lead the operational execution and quality oversight MDR processes, ensuring accurate, timely, and audit-ready documentation of all device-related safety data within the BMS Safety Database

• Develop and maintain combination product safety reporting procedures, defining clear decision rights and workflows to manage dual-reporting obligations (PV + MDR) across jurisdictions.