Director, Digitized Adverse Event Processing & Device Vigilance

Bristol Myers Squibb • Princeton, NJ

2d • Hybrid

About The Position

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.

Requirements

• Minimum Bachelor's degree in Life Sciences, Pharmacy, Medicine, Nursing, Biomedical Engineering, Computer Science, or a related Healthcare or Life Sciences field
• Minimum 10+ years of experience in Pharmacovigilance, Drug Safety, or a closely related field, with at least 3–5 years at Director or equivalent senior leadership level
• Minimum 7 years of hands-on ICSR case processing experience within a pharmaceutical, biotech, or CRO environment
• Demonstrated expertise in digital transformation of PV processes, including deployment of AI, NLP, OCR, RPA, or ML solutions within a regulated GxP environment
• Proven experience with device safety reporting obligations including MDR (21 CFR Part 803), EU MDR/IVDR, and combination product dual-reporting workflows
• Experience with global safety database systems (e.g., Oracle Argus, Veeva Vault Safety, ArisGlobal LifeSphere) and electronic submission platforms (FAERS, EudraVigilance, MHRA Yellow Card)
• Working knowledge of ICH E2B(R3) electronic submission standards and associated data elements
• Prior experience managing geographically distributed, multicultural teams across multiple time zones (US, UK, and India exposure preferred)
• Experience managing regulatory inspections (FDA, EMA, MHRA, or equivalent) related to case management or PV systems
• Track record of vendor and CRO management in the context of outsourced case processing operations

Nice To Haves

• Advanced degree (Master's, PharmD, MD, or PhD) in a relevant discipline is preferred
• Additional qualifications in Digital Health, Data Science, AI/ML, or Health Informatics are highly desirable
• Prior engagement with AI governance frameworks or digital health regulatory policy is an advantage

Responsibilities

• 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.
• 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.
• Partner with BMS Device Development, Regulatory Affairs, and Medical Affairs teams to ensure early identification and correct classification of device-related ICSRs at point of intake
• Monitor regulatory developments in device safety reporting and MRD standards across all BMS operating markets (US, EU, UK, Japan, India, Canada, etc.), and translate these into updated SOPs, training, and process changes
• Provide strategic and operational leadership across a geographically distributed organisation (US, UK, Switzerland, and Japan), ensuring consistent execution of case processing standards, digital workflows, and quality metrics globally
• Ensure alignment of all GxP documentation practices (with a focus on GVP, GCP, and GDP) across all BMS sites and outsourced/partner functions engaged in case processing
• Develop, maintain, and version-control global procedural documents, SOPs, work instructions, and training curricula in accordance with BMS Global Quality Standards and the Quality Management System (QMS)
• Lead cross-functional governance forums and working groups (including Safety, Regulatory, IT, Quality, and Legal/Privacy) to drive alignment on digitized case processing design and the management of device and MRD obligations
• Oversee a Community of Practice (CoP) for case management digitization, defining roles, communication strategies, operating rhythms, and competency levels across regions
• Represent Case Management in enterprise-wide digital transformation programs, safety system upgrades, and regulatory agency interactions as required
• Ensure full compliance with all applicable global pharmacovigilance regulations, including but not limited to: ICH E2B(R3), ICH E2A, ICH E6(R3), GVP Modules VI & VII, 21 CFR Parts 314/600/803, EU MDR 2017/745, MHRA PV regulations, CDSCO PV guidelines, and EU Regulation 2025/1466
• Ensure compliance with GDPR, HIPAA, and BMS data privacy requirements in the handling and electronic submission of personal data within ICSRs, including conformance with EMA GVP Module VI Addendum II (effective July 2025) on masking of personal data
• Serve as the accountable owner for inspection readiness of all digital case processing conventions, AI tools, and device/MRD reporting processes; lead preparation and response for regulatory agency inspections and internal audits
• Define and govern data quality standards across end to end case processing pipeline, including MedDRA coding accuracy, duplicate detection, completeness checks, and audit trail integrity in the BMS safety database
• Ensure all AI/digital tools deployed in the ICSR workflow comply with the EMA's AI pharmacovigilance strategy including risk-based assessment, transparency, explainability, and continuous monitoring requirements
• Lead, mentor, and develop a high-performing, globally diverse team across US, UK, and India, fostering a culture of psychological safety, inclusion, scientific rigor, and continuous improvement
• Define clear role accountabilities, career development pathways, and performance expectations for all direct and matrix reports within the digitized case processing and device/MRD reporting domain
• Drive talent development strategies including upskilling team members in digital literacy, AI/ML fundamentals, and regulatory intelligence to ensure the function remains at the leading edge of PV innovation
• Support vendor relationships and oversee performance of Business Process Outsourcing (BPO) partners and CROs engaged in case management activities, ensuring contractual compliance with quality, regulatory, and digital standards
• Develop and maintain a comprehensive KPI and metrics framework to measure end-to-end ICSR cycle times, digital ingestion rates, automation accuracy, device reporting compliance rates, and MRD quality performance
• Leverage operational analytics and AI-generated dashboards to identify trends, bottlenecks, and opportunities for continuous process improvement
• Benchmark against industry peers and engage with external industry forums (e.g., DIA, CIOMS, PhUSE, ISPE) to ensure BMS case management practices reflect best-in-class standards
• Drive a lean, right-first-time operating culture by embedding quality metrics, error rate tracking, and root cause analysis into standard management rhythms
• Exhibit the BMS behaviours and values

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees