FSP Associate Manager, Safety Data and Systems - Pharmacovigilance

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 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. Support day-to-day operation and troubleshooting of safety systems. Assist in system validation, testing, and deployment of safety systems updates. Generate, validate, and customize safety reports and analytics. Collaborate closely with the pharmacovigilance, clinical, and regulatory teams to ensure safety data management aligns with global regulatory standards (FDA, EMA, PMDA, ICH). Participate in change management processes to enhance safety system integrations. Contribute to audit readiness activities, including system inspections, validation reports, and compliance documentation. Collaborates with internal systems team, BIS/ DT and Safety vendor on issues related to Safety data Performs the generation and quality control of aggregate reports and line listings Initiates and contributes to the development of procedural documents including but not limited to Safety Management Plans, SOPs, work instructions, job aides, forms, or templates Collaborates and co-creates with applicable client functions (e.g. Medical Information, Data Management, Business Information Systems, Quantitative Science) in regards to pharmacovigilance technical aspects, setup and operation Keeps up-to-date on applicable regulatory and PV tech guidelines and shares within GPS and client as applicable. Participates in training related to safety data management Proactively reviews processes and tools and provides suggestions for improvement and better efficiencies   Complete additional task and projects as assigned by line manager or delegate Purpose of the role: Apply AI/ML and NLP methods to safety data (not limited to auto-coding, signal management support, narrative summarization, case triage) within GxP-validated, explainable and regulator-defensible frameworks Lead deliverables for GPS Safety Data Management and Safety System Maintenance activities Provide high quality data outputs for Safety Signal Management, Risk Management and Safety Evidence generation Collaborate and co-create with client functions and applicable vendors as required for seamless GPS Safety Data and Systems operations Education and Experience: At least Bachelors’ degree (or country equivalent) in computer science, data science, computational linguistics, applied statistics/biostatistics, life sciences / Information technology or other relevant field required. Python, ML/NLP frameworks, model deployment/monitoring, MLOps tooling, ideally exposure to LLMs on unstructured clinical/safety text. Familiarity with, or ability to rapidly acquire, GVP/21 CFR 314 concepts preferred working understanding of safety database data models (Argus/ArisG) and E2B(R3) structure. Relevant experience in IT / Safety / Clinical Research / Pharmacovigilance overall with at least 3 years of proven experience with safety database systems (e.g. ARGUS or ArisG) including workflow management Equivalent and adequate combination of education and experience or proven practical expertise in all of the required skills In some cases, an equivalency, consisting of