Director, Digitized Case Processing & Device Vigilance
Core
Architect AI-powered safety operations and digitize ICSR case processing and device vigilance workflows for a global biopharma company.
Role type
Director, Pharmacovigilance & Digital Transformation
Builds
AI/NLP/RPA platforms for ICSR processing, FDA eMDR submissions, and EU MDR/IVDR vigilance reporting
Domain
Biopharmaceuticals, Pharmacovigilance, Regulatory Compliance, AI/ML in Healthcare
Deliverable
production ML models | product features
Required skills
Pharmacovigilance leadership, ICSR case processing, AI/NLP/RPA/ML deployment in GxP, MDR reporting (21 CFR 803, EU MDR/IVDR), combination product workflows, vendor/BPO management, cross-functional governance
Preferred skills
Advanced degree in Life Sciences/CS/AI, Digital Health/Data Science/AI/ML qualifications, experience with Oracle Argus/Veeva/ArisGlobal
Technologies
ArisGlobal LifeSphere, IQVIA Vigilance Detect, Oracle Argus AI, FAERS, EudraVigilance, MHRA Yellow Card, Veeva Vault Safety
Responsibilities
Design multi-year roadmap for intelligent ICSR processing using AI/NLP/RPA/OCR/LLMs; Deploy and validate next-generation platforms in GxP-compliant environments; Govern human-in-the-loop oversight frameworks; Own global Medical Device Reporting obligations and EU MDR/IVDR integration; Lead multicultural teams across US, UK, and India; Drive cross-functional governance with Safety, IT, Quality, and Legal stakeholders; Build KPI frameworks for automation accuracy and compliance
Seniority
Director, strategic leadership with hands-on technical oversight