Director, Digitized Adverse Event Processing & Device Vigilance
Core
Senior leadership role accountable for end-to-end strategy, design, implementation, and continuous improvement of digitized adverse event (AE) case processing workflows and device vigilance reporting using AI, NLP, and RPA.
Role type
Director, Pharmacovigilance & Digital Transformation
Builds
Automated ingestion, triage, and processing of adverse event data from structured and unstructured sources; global Medical Device Reporting (MDR) submissions.
Domain
Life Sciences / Pharmacovigilance / Digital Health
Deliverable
production ML models | product features | dashboards & analysis
Required skills
Digital transformation strategy, AI/NLP/OCR/RPA implementation in GxP, global regulatory compliance (ICH E2B(R3), 21 CFR Part 803, EU MDR), team leadership across time zones, vendor/CRO management, data quality governance, inspection readiness.
Preferred skills
Advanced degree in Life Sciences/Pharmacy/CS, Digital Health/Data Science/AI/ML background, experience with Oracle Argus/Veeva Vault Safety/ArisGlobal LifeSphere.
Technologies
AI, NLP, OCR, RPA, Large Language Models (LLM), Oracle Argus, Veeva Vault Safety, ArisGlobal LifeSphere, FAERS, EudraVigilance.
Responsibilities
Develop multi-year digital transformation roadmap for ICSR case processing; Lead implementation of AI/NLP/OCR/RPA tools for automated data ingestion; Ensure compliance with global pharmacovigilance regulations and device reporting obligations; Lead, mentor, and develop a globally distributed team; Oversee vendor relationships and BPO partners; Define and govern data quality standards and KPI frameworks.
Seniority
Director, strategic leadership with hands-on technical oversight