FSP Associate Manager, Safety Data and Systems - Pharmacovigilance
Core
Design, develop, and validate AI/ML and NLP components for safety operations including MedDRA/WHODrug auto-coding, case triage, duplicate detection, and narrative summarization within GxP-validated frameworks.
Role type
Senior IC machine-learning engineer (pharmacovigilance safety data)
Builds
GxP-validated AI/ML pipelines for safety signal management and automated safety data processing
Domain
Life sciences / Pharmacovigilance / Regulatory Compliance
Deliverable
production ML models
Required skills
Python, ML/NLP frameworks, MLOps tooling, transformer-based models, Named Entity Recognition, text classification, MedDRA/WHODrug auto-coding, GxP/GAMP 5 validation, SQL, safety database systems (Argus/ArisG)
Preferred skills
LLMs on unstructured clinical text, GVP/21 CFR 314 concepts, E2B(R3) structure, prompt engineering, RAG, model explainability (SHAP/LIME)
Technologies
PyTorch, TensorFlow, scikit-learn, pandas, NumPy, MLflow, Azure ML, Databricks, Microsoft 365
Responsibilities
Design and validate AI/ML components for safety operations; manage model lifecycle (versioning, monitoring, retraining); configure and maintain Oracle Argus Safety system; generate and validate safety reports and analytics; collaborate with PV, clinical, and regulatory teams; contribute to audit readiness and compliance documentation.
Seniority
Senior, hands-on IC
