Associate Manager, Safety Data & Systems

🔥 2 minutes ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

👻 Ghost score 15%

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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

• Lead deliverables for Global Patient Safety safety data management and safety system maintenance • Provide high-quality data outputs for safety signal management, risk management, and safety evidence generation • Collaborate with client functions and vendors to support seamless safety data and systems operations • Manage and monitor applicable GPS mailboxes, including unblinded data • Serve as the key technical resource for configuration, maintenance, and administration of the Oracle Argus Safety system • Support day-to-day Argus Safety operations and troubleshoot the application for reliable, compliant drug safety case processing • Assist with validation, testing, and deployment of Argus updates, workflows, and business rules • Generate, validate, and customize safety reports and analytics using Argus reporting tools and business intelligence platforms • Collaborate with pharmacovigilance, clinical, and regulatory teams to align safety data management with FDA, EMA, PMDA, and ICH standards • Participate in change management to improve Argus workflows and system integrations • Contribute to audit readiness, system inspections, validation reports, and compliance documentation • Collaborate with internal systems teams, BIS, and safety vendors on safety database configuration issues • Generate and quality-control aggregate reports and line listings • Develop procedural documents, including Safety Management Plans, SOPs, work instructions, job aids, forms, and templates • Collaborate with Medical Information, Data Management, Business Information Systems, and Quantitative Science functions on pharmacovigilance technical setup and operations • Monitor applicable regulatory and pharmacovigilance technology guidelines and share updates with GPS and clients • 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 Head of GPS Operations

🎯 Requirements

• At least Bachelor’s degree (or country equivalent) in life sciences, Information Technology, or another relevant field • Minimum of 7 years of relevant experience in IT, Safety, Clinical Research, or Pharmacovigilance • At least 3 years of proven experience with safety database systems such as Argus or ArisG, including workflow management • Solid knowledge of global EU, US, and Asia-Pacific pharmacovigilance requirements and practices • Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents, including Europe, US, and Japan • Adequate computer skills in current office applications • Proficiency with Excel; SQL experience is a plus • Proficiency in safety database systems such as Argus and other pharmacovigilance technical systems, including E2B gateways and safety signal detection tools • Proficiency with electronic Safety/PV systems for data visualization, analysis, and dashboards • Robust understanding of end-to-end clinical and post-marketing safety event collection and reporting, including workflow-based case processing and the MedDRA dictionary • Solid understanding of aggregate safety report development and submission, including DSUR and PSUR • Solid understanding of quality management processes, metrics, and KPIs • Fluent written and spoken English • 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 • Ability to communicate effectively and collaborate across functions and with vendors • Equivalent and adequate combination of education and experience or proven practical expertise in all required skills

🏖️ Benefits

• Fully remote work mode • Standard Monday–Friday work schedule

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