FSP Associate Manager, Safety Data and Systems - Pharmacovigilance

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Work Schedule Standard (Mon-Fri) Environmental Conditions Office Job Description Senior Director, Safety Data and Systems, Global Patient Safety or designee Job Description: Design, develop and validate AI/ML and NLP components that support safety operations - including MedDRA/WHODrug auto-coding, case triage, duplicate detection and narrative summarization - with clear human-in-the-loop checkpoints Contribute to model lifecycle management for safety-relevant AI/ML: versioning, monitoring, drift detection, retraining and documentation aligned with GxP / GAMP 5 and internal model governance Support the qualification of AI/ML solutions against evolving regulatory expectations (EMA reflection paper on AI, FDA AI/ML guidance, EU AI Act obligations for high-risk systems) in partnership with…

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