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 a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role
Knowledge, Skills, and Responsibilities:
- Proficiency in Python for ML development, including scikit-learn, pandas, NumPy; experience with at least one deep learning framework (PyTorch or TensorFlow).
- Natural language processing for extraction of adverse events, drugs, and outcomes from unstructured text - case narratives, medical literature, call transcripts, and spontaneous reports.
- Named Entity Recognition (NER), relation extraction, and text classification
- Experience with transformer-based / large language models (BERT-family, clinical/biomedical models such as BioBERT or PubMedBERT, and modern LLMs) for narrative generation, summarization, and information extraction.
- MedDRA and WHODrug auto-coding using ML/NLP; prompt engineering and retrieval-augmented generation (RAG) a plus.
- Supervised and unsupervised methods for classification, clustering, and anomaly detection.
- Feature engineering and model evaluation (precision/recall trade-offs, ROC/AUC, calibration) with an understanding of why recall and sensitivity are weighted heavily in a safety context.
- Model lifecycle management: versioning, monitoring, drift detection, retraining pipelines using standard MLOps tooling (e.g. MLflow, Azure ML, Databricks) in line with client DT/BIS standards
- Model explainability / interpretability (SHAP, LIME) - essential where decisions must be defensible to health authorities.
- Understanding of GxP / GAMP 5 validation as applied to AI/ML systems, model governance, and emerging regulatory expectations (EMA reflection paper on AI, FDA guidance) — rare and worth flagging as preferred.
- Proficiency in Safety Database systems (e.g. Argus) and knowledge of other technical systems applicable to Safety /Pharmacovigilance (e.g. E2B gateway, safety signal detection tools and systems) is a plus.
- Proficiency in electronic systems commonly used for Safety / PV, like for data visualization and analysis, dashboards
- Solid understanding of the quality management processes, metrics and KPIs
- Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)
- Proficient in the Microsoft 365 stack (Excel, Word, PowerPoint, Teams, SharePoint, OneDrive) and in modern collaboration and documentation tooling
- Advanced Excel required; working proficiency in SQL required for querying safety and operational datasets
- Ability to communicate effectively and collaborate successfully across functions and with vendors
- Fluent communication in written and spoken English required
- Ability to work independently with minimal oversight and prioritize effectively
- Ability to complete multiple complex deliverables within tight timelines
- Ability to function effectively in a team environment
Working Environment:
Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.