Associate Manager, Safety Data and Systems

Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back. argenx is preparing for multi-dimensional expansion to reach more patients through a rich pipeline of differentiated assets, led by VYVGART, our first-in-class neonatal Fc receptor blocker approved for the treatment of gMG, and with the potential to treat patients across dozens of severe autoimmune diseases.

We are building a new kind of biotech company, one that maintains its roots as a science-based start-up and pushes our commitment to innovate across all corners of our business. We strive to inspire and grow our company, our partnerships, our science, and our people, because when we do, we deliver more for patients. 

The Associate Manager, Safety Data and Systems will:

• 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

• Collaborate and co-create with argenx functions and applicable vendors as required for seamless GPS Safety Data and Systems operations

ROLES AND RESPONSIBILITIES

• Manages and monitors applicable GPS mailboxes including unblinded data

• Serve as the key technical resource for the configuration, maintenance, and administration of the Oracle Argus Safety system.

• Support day-to-day operation and troubleshooting of Argus Safety application to ensure reliable and compliant drug safety case processing.

• Assist in system validation, testing, and deployment of Argus Safety system updates, workflows, and business rules.

• Generate, validate, and customize safety reports and analytics using Argus reporting tools and associated business intelligence platforms.

• Collaborate closely with the pharmacovigilance, clinical, and regulatory teams to ensure safety data management aligns with global regulatory standards (FDA, EMA, PMDA, ICH).

• Participate in change management processes to enhance Argus Safety system workflows and system integrations.

• Contribute to audit readiness activities, including system inspections, validation reports, and compliance documentation.

• Collaborates with internal systems team, BIS and Safety vendor on issues related to Safety database configurations

• Performs the generation and quality control of aggregate reports and line listings

• Initiates and contributes to the development of procedural documents including but not limited to Safety Management Plans, SOPs, work instructions, job aides, forms, or templates

• Collaborates and co-creates with applicable argenx functions (e.g. Medical Information, Data Management, Business Information Systems, Quantitative Science) in regards to pharmacovigilance technical aspects, setup and operation

• Keeps up-to-date on applicable regulatory and PV tech guidelines and shares within GPS and argenx as applicable.

• Participates in training related to safety data management

• Proactively reviews processes and tools and provides suggestions for improvement and better efficiencies  

• Complete additional task and projects as assigned by line manager or Head of GPS Operations or delegate

SKILLS AND COMPETENCIES

• Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan)

• Adequate computer skills in all current office applications

• Proficiency with Excel is required, experience with SQL is a plus

• Proficiency in Safety Database systems (e.g. Argus) and knowledge of other technical systems applicable to Safety /Pharmacovigilance (e.g. E2B gateway, safety signal detection tools and systems).

• Proficiency in electronic systems commonly used for Safety / PV, like for data visualization and analysis, dashboards

• Robust understanding of the end to end process of clinical and post-marketing safety event collection and reporting including of workflow based case processing and MedDRA dictionary

• Solid understanding of the development and submission of aggregate safety reports (e.g. DSUR, PSUR)

• Solid understanding of the quality management processes, metrics and KPIs

• Ability to communicate effectively and collaborate successfully across functions and with vendors

• Fluent communication in 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