Director, Digitized Adverse Event Processing & Device Vigilance
Bristol Myers Squibb
5 days ago
Remote friendly (Princeton, NJ)
United States
Operations
Position Summary
- Lead end-to-end strategy, design, implementation, and continuous improvement of digitized adverse event (AE) case processing workflows within BMS PV Operations & Systems.
Responsibilities
- Build and execute a multi-year digital transformation roadmap for ICSR case processing (aligned to enterprise AI and PV Operations).
- Implement AI/NLP/OCR/RPA and LLM-assisted tools for automated ingestion, triage, and processing of structured/unstructured adverse event data.
- Partner with Digital & Technology and vendors to evaluate/validate/deploy intelligent case processing platforms.
- Define/govern human-in-the-loop oversight for qualified medical/safety review of AI-assisted decisions; support AI/ML validation in GxP-regulated environments.
- Champion ICH E2B(R3) digital submission standards.
- Own global MDR obligations (21 CFR 803), ensuring timely eMDR submissions; oversee EU MDR/IVDR device-related PV obligations and device-malfunction integration to EudraVigilance.
- Lead MDR process quality/documentation and maintain PV+MDR dual-reporting procedures across jurisdictions.
- Provide global process leadership and governance: GxP-aligned documentation, SOP/work instruction version control, cross-functional forums, and a Community of Practice for digitization.
- Ensure regulatory compliance and data privacy (GDPR/HIPAA, EMA masking requirements), inspection readiness, and data quality standards.
- Lead a globally distributed team; develop talent and oversee BPO/CRO performance.
- Drive KPIs/analytics and continuous improvement (cycle time, ingestion, automation accuracy, compliance, MRD quality).
Qualifications
- BS minimum in life sciences/healthcare/biomedical engineering/CS or related; MS/PharmD/MD/PhD preferred; Digital Health/Data Science/AI-ML/Health Informatics desirable.
- 10+ years PV/Drug Safety with 3–5 years director/senior leadership; 7+ years hands-on ICSR case processing (pharma/biotech/CRO).
- Demonstrated PV digital transformation in regulated GxP; device safety/MDR (21 CFR 803, EU MDR/IVDR) and dual-reporting experience.
- Experience with safety databases (Oracle Argus, Veeva Vault Safety, ArisGlobal LifeSphere) and e-submission platforms (FAERS, EudraVigilance, MHRA Yellow Card).
- Working knowledge of ICH E2B(R3); experience managing distributed multicultural teams; inspection management experience preferred.
Benefits (explicitly listed)
- Health coverage (medical/pharmacy/dental/vision); wellbeing support (EAP and related programs); financial protection (401(k), disability/life insurance, accident/supplemental coverage, travel protection, legal support, survivor support).
- Paid Time Off: flexible time off (US exempt) or annual paid vacation (specified locations), 11 paid national holidays; additional time off options and Global Shutdown (eligibility-based).
Application instructions
- If the role isn’t a perfect resume match, apply anyway.
- Lead end-to-end strategy, design, implementation, and continuous improvement of digitized adverse event (AE) case processing workflows within BMS PV Operations & Systems.
Responsibilities
- Build and execute a multi-year digital transformation roadmap for ICSR case processing (aligned to enterprise AI and PV Operations).
- Implement AI/NLP/OCR/RPA and LLM-assisted tools for automated ingestion, triage, and processing of structured/unstructured adverse event data.
- Partner with Digital & Technology and vendors to evaluate/validate/deploy intelligent case processing platforms.
- Define/govern human-in-the-loop oversight for qualified medical/safety review of AI-assisted decisions; support AI/ML validation in GxP-regulated environments.
- Champion ICH E2B(R3) digital submission standards.
- Own global MDR obligations (21 CFR 803), ensuring timely eMDR submissions; oversee EU MDR/IVDR device-related PV obligations and device-malfunction integration to EudraVigilance.
- Lead MDR process quality/documentation and maintain PV+MDR dual-reporting procedures across jurisdictions.
- Provide global process leadership and governance: GxP-aligned documentation, SOP/work instruction version control, cross-functional forums, and a Community of Practice for digitization.
- Ensure regulatory compliance and data privacy (GDPR/HIPAA, EMA masking requirements), inspection readiness, and data quality standards.
- Lead a globally distributed team; develop talent and oversee BPO/CRO performance.
- Drive KPIs/analytics and continuous improvement (cycle time, ingestion, automation accuracy, compliance, MRD quality).
Qualifications
- BS minimum in life sciences/healthcare/biomedical engineering/CS or related; MS/PharmD/MD/PhD preferred; Digital Health/Data Science/AI-ML/Health Informatics desirable.
- 10+ years PV/Drug Safety with 3–5 years director/senior leadership; 7+ years hands-on ICSR case processing (pharma/biotech/CRO).
- Demonstrated PV digital transformation in regulated GxP; device safety/MDR (21 CFR 803, EU MDR/IVDR) and dual-reporting experience.
- Experience with safety databases (Oracle Argus, Veeva Vault Safety, ArisGlobal LifeSphere) and e-submission platforms (FAERS, EudraVigilance, MHRA Yellow Card).
- Working knowledge of ICH E2B(R3); experience managing distributed multicultural teams; inspection management experience preferred.
Benefits (explicitly listed)
- Health coverage (medical/pharmacy/dental/vision); wellbeing support (EAP and related programs); financial protection (401(k), disability/life insurance, accident/supplemental coverage, travel protection, legal support, survivor support).
- Paid Time Off: flexible time off (US exempt) or annual paid vacation (specified locations), 11 paid national holidays; additional time off options and Global Shutdown (eligibility-based).
Application instructions
- If the role isn’t a perfect resume match, apply anyway.