Associate Manager, Safety Data and Systems – Pharmacovigilance

🔥 2 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟡 Mid-level

🧪 Clinical Research

👻 Ghost score 12%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

🧬 Biotechnology

💊 Pharmaceuticals

🏥 Healthcare

Biotechnology • Pharmaceuticals • Healthcare

Thermo Fisher Scientific is the world leader in serving science, with a stated mission to enable customers to make the world healthier, cleaner and safer. The company provides a broad portfolio of laboratory instruments, analytical technologies, diagnostics, consumables, software and services that support life‑sciences research, analytical testing, clinical diagnostics and the development and manufacture of therapies. Its operations and offerings (as described on its site and in its news) include advanced imaging and electron microscopes, chromatography and mass‑spectrometry systems, genetic and clinical testing, lab automation and AI tools, bioprocessing and contract development/manufacturing services (brands cited include Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD). Thermo Fisher reports annual revenue over $45 billion and emphasizes corporate social responsibility, environmental and community programs alongside its scientific products and services.

📋 Description

• Design, develop, and validate AI/ML and NLP components supporting safety operations, including auto-coding, case triage, duplicate detection, and narrative summarization • Implement human-in-the-loop checkpoints for safety-relevant AI/ML solutions • Contribute to model lifecycle management, including versioning, monitoring, drift detection, retraining, and documentation • Support qualification of AI/ML solutions against EMA, FDA, and EU AI Act expectations • Serve as technical resource for configuration, maintenance, and administration of Oracle Argus Safety • Support daily 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, internal systems, BIS/DT, vendors, and client functions • Support alignment of safety data management with FDA, EMA, PMDA, and ICH standards • Participate in change management for 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 aids, forms, and templates • Maintain current knowledge of regulatory and pharmacovigilance technology guidelines and share updates • Participate in safety data management training • Review processes and tools and recommend efficiency improvements • Complete additional tasks and projects assigned by the line manager or delegate • Lead deliverables for GPS Safety Data Management and Safety System Maintenance • Provide high-quality data outputs for Safety Signal Management, Risk Management, and Safety Evidence generation

🎯 Requirements

• At least a 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, training, and/or directly related experience may be considered • At least 3 years of proven experience with safety database systems such as ARGUS or ArisG, including workflow management • Relevant experience in IT, Safety, Clinical Research, or Pharmacovigilance • Proficiency in Python, including scikit-learn, pandas, and NumPy • Experience with at least one deep learning framework: PyTorch or TensorFlow • Experience with NLP, including adverse-event, drug, and outcome extraction from unstructured text • Knowledge of named entity recognition, relation extraction, and text classification • Experience with transformer-based or large language models, including BERT-family, BioBERT, PubMedBERT, or modern LLMs • Experience with MedDRA and WHODrug auto-coding using ML/NLP • Knowledge of supervised and unsupervised classification, clustering, and anomaly detection • Knowledge of feature engineering and model evaluation, including precision/recall, ROC/AUC, and calibration • Experience with model lifecycle management, versioning, monitoring, drift detection, and retraining pipelines • Knowledge of MLOps tooling such as MLflow, Azure ML, or Databricks • Knowledge of model explainability/interpretability tools such as SHAP and LIME • Understanding of GxP/GAMP 5 validation, model governance, and emerging AI/ML regulatory expectations • Proficiency in safety database systems such as Argus and knowledge of E2B gateways and safety signal detection systems is a plus • Proficiency with electronic Safety/PV systems for data visualization, analysis, and dashboards • Solid understanding of quality management processes, metrics, and KPIs • Knowledge of pharmacovigilance regulatory requirements and guidance for Europe, the US, and Japan • Proficiency in Microsoft 365, including Excel, Word, PowerPoint, Teams, SharePoint, and OneDrive • Advanced Excel skills • Working proficiency in SQL for querying safety and operational datasets • Fluent written and spoken English • Ability to work independently, prioritize effectively, complete multiple complex deliverables under tight timelines, communicate across functions, collaborate with vendors, and function effectively in a team environment

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule • Health and wellbeing support • Support and encouragement to create a healthy and balanced work environment

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