Description
The Senior Director, Safety Data and Systems, Global Patient Safety or designee leads AI/ML and NLP development for safety operations, including MedDRA/WHODrug auto-coding, case triage, duplicate detection, narrative summarization, and model lifecycle management under GxP/GAMP 5 and emerging regulatory frameworks. The role also administers and troubleshoots Oracle Argus Safety, supports validation and deployment, generates safety analytics, and collaborates with pharmacovigilance, clinical, regulatory, quality, and vendor teams. It requires a relevant bachelor’s degree, at least three years of safety database experience, Python and ML/NLP expertise, and strong knowledge of pharmacovigilance systems and regulations.
