FSP Associate Manager, Safety Data & Systems

🔥 1 minute ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

👔 Manager

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Lead deliverables for Global Patient Safety safety data management and safety system maintenance activities • Provide high-quality data outputs for safety signal management, risk management, and safety evidence generation • 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 operation and troubleshooting for reliable and compliant drug safety case processing • Assist with system 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 client functions on pharmacovigilance technical setup and operations • Keep current on regulatory and pharmacovigilance technology guidelines and share updates with GPS and clients • Participate in safety data management training • Review processes and tools proactively and suggest 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 required • 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 required; SQL experience is a plus • Proficiency in safety database systems, such as Argus, and knowledge of 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, workflow-based case processing, and MedDRA dictionary • Solid understanding of development and submission of aggregate safety reports, such as DSUR and PSUR • Solid understanding of quality management processes, metrics, and KPIs • Fluent written and spoken English required • 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 • Equivalent and adequate combination of education and experience or proven practical expertise in all required skills

🏖️ Benefits

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