Associate Manager, Safety Data and Systems – Pharmacovigilance

🕒 September 16

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 20%

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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-relevant AI/ML solutions • Contribute to AI/ML 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 • Configure, maintain, and administer the Oracle Argus Safety system • 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, internal systems, BIS/DT, safety vendors, and client functions • 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 aids, forms, and templates • Keep current on regulatory and pharmacovigilance technology guidelines and share updates • Participate in safety data management training • Review processes and tools and suggest improvements and efficiencies • 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 and adequate combination of education and experience or proven practical expertise in all required skills 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 for ML development, including scikit-learn, pandas, and NumPy • Experience with at least one deep learning framework: PyTorch or TensorFlow • NLP experience for extracting adverse events, drugs, and outcomes from unstructured text • Experience with NER, relation extraction, and text classification • Experience with transformer-based/large language models, including BERT-family, BioBERT, PubMedBERT, and modern LLMs • Experience with 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, versioning, monitoring, drift detection, and retraining pipelines using MLOps tooling • Model explainability/interpretability experience with SHAP and LIME • Understanding of GxP/GAMP 5 validation, AI/ML model governance, and regulatory expectations • Working understanding of safety database data models such as Argus/ArisG and E2B(R3) structure • Advanced Excel required; working proficiency in SQL required • Proficiency in Microsoft 365 and modern collaboration/documentation tools • Solid understanding of quality management processes, metrics, and KPIs • Good knowledge of pharmacovigilance regulatory requirements and guidance for Europe, the US, and Japan • Fluent written and spoken English required • Ability to work independently, prioritize effectively, complete multiple complex deliverables within tight timelines, and function effectively in a team environment

🏖️ Benefits

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