Associate Manager, Safety Data and Systems

🕒 Agosto 12

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $88.000 - $121.000 / ano

⏰ Tempo Integral

🟢 Júnior

🟡 Pleno

👔 Gerente

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

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argenx

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2008

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

A argenx é uma empresa de biotecnologia comprometida em melhorar a vida dos pacientes por meio de inovação em imunologia. A empresa concentra-se no desenvolvimento de terapias inovadoras baseadas em anticorpos para tratar doenças autoimunes graves. Adotando uma abordagem colaborativa com cientistas pioneiros e parceiros acadêmicos, a argenx acelera a descoberta de anticorpos terapêuticos que têm como alvo vias específicas das doenças. Os produtos proprietários da empresa, como o efgartigimod, têm como objetivo tratar doenças em que os anticorpos IgG são patogênicos. A argenx enfatiza a inovação, a ciência da colaboração e abordagens centradas no paciente em sua missão de oferecer soluções médicas transformadoras.

Descrição

• Lead deliverables for GPS 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 operation and troubleshooting of the Argus Safety application • Assist in system validation, testing, and deployment of Argus Safety 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 global regulatory standards • Participate in change management processes to enhance system workflows and integrations • Contribute to audit readiness, 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 argenx functions on pharmacovigilance technical aspects, setup, and operation • 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 Head of GPS Operations

🎯 Requisitos

• At least Bachelor's degree (or country equivalent) in life sciences, Information Technology, or another relevant field required • Solid knowledge of global EU, US, and Asia-Pacific pharmacovigilance requirements and practices • Minimum 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 • Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents for Europe, the US, and Japan • Adequate computer skills in current office applications • Proficiency with Excel required • Experience with SQL is a plus • Proficiency in safety database systems such as Argus • Knowledge of technical systems applicable to safety/pharmacovigilance, including E2B gateways and safety signal detection tools • Proficiency in electronic systems used for safety/pharmacovigilance data visualization, analysis, and dashboards • Understanding of end-to-end clinical and post-marketing safety event collection and reporting, workflow-based case processing, and MedDRA dictionary • Understanding of development and submission of aggregate safety reports such as DSUR and PSUR • 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

• Annual base salary range of $88,000.00 - $121,000.00 USD • Eligibility to participate in short-term incentive programs • Eligibility to participate in long-term incentive programs • Comprehensive benefits package • Retirement savings plans • Health benefits • Inclusive environment • Equal consideration for employment without discrimination