Associate Manager, Safety Data and Systems – Pharmacovigilance

🕒 September 16

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

👔 Manager

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👻 Ghost score 39%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Design, develop, and validate AI/ML and NLP components supporting safety operations, including auto-coding, case triage, duplicate detection, and narrative summarization • Maintain human-in-the-loop checkpoints for safety AI/ML solutions • Contribute to model lifecycle management, including versioning, monitoring, drift detection, retraining, and documentation • Support qualification of AI/ML solutions against regulatory expectations in partnership with Quality, DT/BIS, and GPS Signal Management • Serve as the key technical resource for configuration, maintenance, and administration of Oracle Argus Safety • Support day-to-day operation and troubleshooting of safety systems • Assist with system validation, testing, and deployment of safety system updates • Generate, validate, and customize safety reports and analytics • Collaborate with pharmacovigilance, clinical, regulatory, client, internal systems, and vendor teams • Participate in change management to enhance safety system integrations • Contribute to audit readiness, inspections, validation reports, and compliance documentation • Generate and quality-control aggregate reports and line listings • Develop procedural documents, including Safety Management Plans, SOPs, work instructions, job aides, forms, and templates • Support pharmacovigilance technical setup and operations with client functions • Keep current with regulatory and pharmacovigilance technology guidelines and share updates • Participate in safety data management training • Review processes and tools and suggest efficiency improvements • Complete additional tasks and projects assigned by the line manager or delegate

🎯 Requirements

• At least Bachelor’s degree (or country equivalent) in computer science, data science, computational linguistics, applied statistics/biostatistics, life sciences, information technology, or another relevant field • Equivalent combination of education and experience or proven practical expertise may be considered • At least 3 years of proven experience with safety database systems such as ARGUS or ArisG, including workflow management • Proficiency in Python, including scikit-learn, pandas, and NumPy • Experience with at least one deep learning framework: PyTorch or TensorFlow • Natural language processing experience for extracting adverse events, drugs, and outcomes from unstructured text • Experience with named entity recognition, relation extraction, and text classification • Experience with transformer-based or large language models, including BERT-family, BioBERT, PubMedBERT, or modern LLMs • Knowledge of MedDRA and WHODrug auto-coding using ML/NLP • Knowledge of supervised and unsupervised classification, clustering, and anomaly detection • Experience with feature engineering and model evaluation, including precision/recall, ROC/AUC, and calibration • Experience with model lifecycle management, including versioning, monitoring, drift detection, and retraining pipelines • Knowledge of model explainability and interpretability, including SHAP and LIME • Understanding of GxP/GAMP 5 validation, AI/ML model governance, and emerging regulatory expectations • Working understanding of safety database data models such as Argus/ArisG and E2B(R3) structure • Advanced Excel skills • Working proficiency in SQL for querying safety and operational datasets • Proficiency in Microsoft 365 and modern collaboration/documentation tools • Knowledge of pharmacovigilance regulatory requirements and guidance for Europe, the US, and Japan • Understanding of quality management processes, metrics, and KPIs • Fluent written and spoken English • Ability to communicate and collaborate across functions and with vendors • 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

🏖️ Benefits

• Fully remote work arrangement • Standard Monday–Friday work schedule • Healthy and balanced working environment supported by Thermo Fisher Scientific

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