FSP Associate Manager, Safety Data & Systems

🕒 Outubro 22

🌲 North Carolina – Remoto

🌲 North Carolina – Remote

⏰ Tempo Integral

🟠 Sênior

🔴 Especialista

👔 Gerente

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• Sem salário divulgado.

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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

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