Safety Scientist

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🔥 3 minutes ago

🇺🇸 United States – Remote

💵 $164k - $225.5k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

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argenx

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 2008

🧬 Biotechnology

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

• Conduct continuous review and analysis of aggregate safety data from clinical trials, post-marketing individual case safety reports (ICSRs), literature, registries, and external databases. • Identify 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, identify 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 medicines. • Perform medical coding checks, case series reviews, and standardize MedDRA search strategies. • Define data acquisition strategy, methodology, and approach for safety evaluations. • Assist in the assessment and management of medical safety data, and in the development and execution of safety signal and benefit–risk management strategies. • Contribute and perform analysis and participate actively in safety governance meetings. • Lead and participate in the planning, preparation, drafting and review of periodic safety reports.

🎯 Requirements

• Master’s or doctoral degree in pharmacy, nursing, healthcare or other life sciences or technical fields • Minimum of 5-7 years of pharmacovigilance/safety risk management experience • Experience working with quantitative or real-world safety data and, ideally, with signal-detection or benefit–risk analytics; grounding in statistics or epidemiology is a plus. • Experience using GenAI or analytics tools to support drafting of safety documents and data exploration • Familiarity with structured, reproducible, and traceable analysis workflows supporting transparent and auditable safety analyses is a plus. • Knowledge of pharmacovigilance as applies to safety signal management, safety data review in clinical and post-marketing settings • Ability to assemble, analyze and disseminate knowledge gathered from disparate data sources to drive benefit-risk decision making • Ability to communicate complex issues effectively • Ability to influence and collaborate with multidisciplinary teams • Fluency in written and spoken English.

🏖️ Benefits

• Comprehensive benefits package • Retirement savings plans • Health benefits