FSP Associate Manager, Safety Data and Systems - Pharmacovigilance

Thermo Fisher Scientific · Remote

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Role summary

Thermo Fisher Scientific seeks an Associate Manager for Safety Data and Systems to design and deploy AI/ML solutions for pharmacovigilance operations. The role combines machine learning development with Oracle Argus Safety system administration, regulatory compliance, and collaboration across clinical and safety teams.

What they're looking for

Bachelor's degree in computer science, data science, statistics, life sciences, or related field
3+ years experience with safety database systems (Argus or ArisG) and workflow management
Python proficiency with ML/NLP frameworks (scikit-learn, PyTorch, TensorFlow); deep learning experience required
Natural language processing expertise including NER, relation extraction, and text classification
Experience with transformer-based models and large language models for clinical text
Working knowledge of GVP, 21 CFR 314, E2B(R3) structure, and MedDRA/WHODrug coding preferred

What you'll be doing

Design, develop, and validate AI/ML and NLP components for safety operations with human-in-the-loop checkpoints
Manage model lifecycle including versioning, monitoring, drift detection, and retraining aligned with GxP standards
Configure, maintain, and administer Oracle Argus Safety system; support troubleshooting and system updates
Generate, validate, and customize safety reports; perform quality control of aggregate reports and line listings
Collaborate with pharmacovigilance, clinical, regulatory, and internal teams to ensure compliance with global standards

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Date posted2 days ago

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