Associate Manager, Safety Data and Systems – Pharmacovigilance

🔥 16 hours ago

🌲 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 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

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 • Contribute to safety-relevant 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 • Serve as the key technical resource for configuration, maintenance, and administration of 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, client, internal systems, BIS/DT, 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 aids, forms, and templates • Stay current on regulatory and pharmacovigilance technology guidelines and share updates • Participate in safety data management training • Review processes and tools and recommend efficiency improvements • Lead GPS Safety Data Management and Safety System Maintenance deliverables • Provide high-quality data outputs for Safety Signal Management, Risk Management, and Safety Evidence generation • 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 • 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 • Equivalent combination of education and experience or proven practical expertise may be considered • Proficiency in Python, including scikit-learn, pandas, and NumPy • Experience with at least one deep learning framework, such as PyTorch or TensorFlow • Experience with NLP, including adverse-event, drug, and outcome extraction 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 • 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 such as MLflow, Azure ML, or Databricks • Model explainability/interpretability experience with SHAP or LIME • Understanding of GxP/GAMP 5 validation, AI/ML model governance, and emerging regulatory expectations • Working understanding of safety database data models, including Argus/ArisG, and E2B(R3) structure • Advanced Excel and working proficiency in SQL required • Proficiency in Microsoft 365 and collaboration/documentation tools • Solid understanding of quality management processes, metrics, and KPIs • Good knowledge of pharmacovigilance regulatory requirements and guidance documents covering 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 • Healthy and balanced working environment supported by Thermo Fisher Scientific