Associate Manager, Safety Data and Systems

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🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $88k - $121k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

👔 Manager

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

argenx is a biotechnology company committed to improving the lives of patients through immunology innovation. The company focuses on developing novel antibody-based therapies to treat severe autoimmune diseases. Using a collaborative approach with pioneering scientists and academic partners, argenx accelerates the discovery of therapeutic antibodies that target specific disease pathways. The company's proprietary products, such as efgartigimod, are aimed at treating diseases where IgG antibodies are pathogenic. Argenx emphasizes innovation, science of collaboration, and patient-centric approaches in its mission to deliver life-changing medical solutions.

📋 Description

• 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

🎯 Requirements

• 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

🏖️ Benefits

• 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