Safety Scientist

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $164k - $225.5k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

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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

• Conduct continuous review and analysis of aggregate safety data from clinical trials, post-marketing ICSRs, literature, registries, and external databases • Identify data, analytical, and process improvements for signal detection • Leverage data, analytics, visualization, and AI-supported outputs for signal detection and benefit–risk assessment • Critically interpret safety database, analytics, and AI-enabled tool outputs • Contribute to design, testing, and improvement of data-driven and automated safety-surveillance workflows • Identify opportunities to improve knowledge of patient treatment, drugs, interactions, and treatment pathways • Perform medical coding checks, case series reviews, and standardize MedDRA search strategies • Define data acquisition strategies, methodologies, and approaches for safety evaluations • Assist with medical safety data assessment and safety signal and benefit–risk management strategies • Contribute analyses and participate in Safety Management Team and Benefit–Risk Committee meetings • Lead and participate in preparation and review of DSURs, PBRERs/PSURs, and PADERs • Facilitate cross-functional input from clinical, nonclinical, regulatory, and statistical teams • Support end-to-end signal management and signal detection activities • Lead identification, analysis, and evaluation of safety signals from internal and external sources • Conduct regular literature reviews for new product safety information • Assist with RMP and REMS development, maintenance, and execution • Support safety labeling and Core Data Sheet updates • Represent safety cross-functionally and support responses to regulatory safety inquiries • Partner with Safety Operations on case quality, MedDRA coding, and processing conventions • Collaborate on clinical documents including CSRs, IBs, protocols, and SAPs • Contribute to audits and regulatory inspections • Support GPS SOPs and controlled documents • Contribute to maintenance of safety databases and tools • Participate in cross-functional projects and departmental activities

🎯 Requirements

• Master’s or doctoral degree in pharmacy, nursing, healthcare, other life sciences, or technical fields (MS, PharmD, or PhD) • Minimum of 5–7 years of pharmacovigilance/safety risk management experience • Experience with quantitative or real-world safety data • Knowledge of pharmacovigilance for safety signal management and clinical/post-marketing safety data review • Knowledge of relevant global pharmacovigilance regulations and guidelines • Ability to prepare and/or review periodic aggregate safety reports, signal evaluation reports, or risk management plans • Experience with MedDRA and WHO Drug Dictionary • Understanding of databases, querying data sources, and search strategies • Strong digital literacy, including safety and real-world datasets and dashboards, analytics, and AI/system-generated outputs • Fluency in written and spoken English • Experience with signal-detection or benefit–risk analytics, statistics, or epidemiology is advantageous • Experience using GenAI or analytics tools for safety-document drafting and data exploration is advantageous • Familiarity with structured, reproducible, and traceable analysis workflows is advantageous • Familiarity with Python, R, SQL, SAS, Power BI, Tableau, or Spotfire is advantageous • Familiarity with AI/ML methods relevant to signal detection and automation of safety-surveillance tasks is advantageous

🏖️ Benefits

• Short-term incentive program eligibility • Long-term incentive program eligibility • Comprehensive benefits package • Retirement savings plans • Health benefits • Equal consideration for employment without discrimination • Reasonable accommodation during application, interviewing, and candidate selection processes