Safety Scientist

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 Safety Scientist is responsible for  the ongoing safety surveillance of assigned investigational and/or marketed products. The safety scientist directs a cross functional team comprised of and Medical Safety, Clinical Development, Regulatory Affairs, Biostatistics, and Safety Operations to ensure timely evaluation of safety data, identification of safety signals, and preparation of high-quality safety deliverables. The Safety Scientist contributes to proactive benefit–risk assessment and compliance with global safety reporting requirements. Effective communication and influence with internal and external stakeholders are essential. This role represents GPS Safety Science internally and externally at a global level and functions. The role also applies digital and data fluency — using analytics, visualization, and AI-supported outputs, with sound scientific judgment and awareness of their limitations — to strengthen signal detection and benefit–risk assessment.ROLES AND RESPONSIBILITIESConduct continuous review and analysis of aggregate safety data from clinical trials, post-marketing individual case safety reports (ICSRs), literature, registries, and external databases.Identifies data, analytical, or process improvements that increase the likelihood of detecting a signal or decrease the time to signal detection.Leverage data, analytics, visualization, and AI-supported outputs to enhance signal detection, aggregate safety review, and benefit–risk assessment.Critically review and interpret outputs from safety databases, analytics, and AI-enabled tools, applying appropriate scientific judgment and awareness of data limitations, bias, and confounding.Contribute to the design, testing, and continuous improvement of data-driven and automated safety-surveillance workflows, in alignment with quality, validation, and regulatory requirements.In conjunction with safety physician team members, identifies opportunities to increase knowledge of patient treatment, drugs and interactions, and treatment pathways that drive actions and decisions to ensure the safe use of argenx medicinesPerform medical coding checks, case series reviews, and standardize MedDRA search strategies.Define data acquisition strategy, methodology, an...