FSP Associate Manager, Safety Data and Systems - Pharmacovigilance

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 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 a