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FSP Associate Manager, Safety Data and Systems - Pharmacovigilance
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Job Title: FSP Associate Manager, Safety Data and Systems - Pharmacovigilance Job Location: Remote, North Carolina, USA Job Location Type: Remote Job Contract Type: Full-time Job Seniority Level: Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionSenior Director, Safety Data and Systems, Global Patient Safety or designeeJob 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 Quality, DT/BIS and GPS Signal Management • Serve as the key technical resource for the configuration, maintenance, and administration of the Oracle Argus Safety system.