argenx
Safety Scientist
United States - Remote
Sponsorship not specified$164k-$226kDetected 1 day ago
PythonSQLMachine LearningData VisualizationNLPComputer VisionStatisticsICD-10Clinical TrialsFDA RegulatoryPharmacovigilanceSASCommunicationProblem SolvingBiostatisticsEpidemiologyRegulatory Affairs
About the role
- The Safety Scientist is responsible for the ongoing safety surveillance of assigned investigational and/or marketed products.
- 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.
Responsibilities
- 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 medicines
- Lead and participate in the planning, preparation, drafting and review of periodic safety reports, including DSURs, PBRERs/PSURs and PADERs.
- Support the end-to-end signal management process and perform signal detection activities through generation of routine outputs and initial trend evaluations using the appropriate tools and methodologies
- Lead the identification, analysis, and evaluation of safety signals that arise from multiple internal and external data sources
- 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.
- Contribute to the design, testing, and continuous improvement of data-driven and automated safety-surveillance workflows, in alignment with quality, validation, and regulatory requirements.
- Support updates to safety labelling sections and Core Data Sheets (CDS), including reviewing proposed safety language and references
- Support responses to regulatory safety inquiries
- Partner with Safety Operations on case quality issues, MedDRA coding, and case processing convention
- Contribute and collaborate with Clinical, Regulatory, and Biostatistics teams to development and review of clinical documents, including CSRs, IBs, protocols, and SAPs
Requirements
- Minimum of 5-7 years of pharmacovigilance/safety risk management experience
- Master's or doctoral degree in pharmacy, nursing, healthcare or other life sciences or technical fields (MS, PharmD. or PhD)
- 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, with a clear understanding of their limitations and the requirement for scientific oversight, is a plus.
Nice to have
- grounding in statistics or epidemiology is a plus.
- Familiarity with structured, reproducible, and traceable analysis workflows (e.g. version control or notebooks-as-code) supporting transparent and auditable safety analyses is a plus.
Skills
- Knowledge of pharmacovigilance as applies to safety signal management, safety data review in clinical and post-marketing settings
- Knowledge of relevant global pharmacovigilance regulations and guidelines
- Ability to communicate complex issues effectively
- Ability to influence and collaborate with multidisciplinary teams
- Ability to prioritize and plan proactively
- Excellent analytical and problem-solving skills, with sound autonomy and applied judgment
- Experience with MedDRA, WHO Drug Dictionary
- Fluency in written and spoken English
Compensation
- The annual base salary hiring range for this position is $164,000.00 - $225,500.00 USD.
Benefits
- Individual compensation is determined using objective, inclusive, and job-related criteria such as relevant experience, skills, demonstrated competencies and internal equity.
- It also includes a comprehensive benefits package, including but not limited to retirement savings plans, health benefits and other benefits subject to the terms of the applicable plans and program guidelines.
- Leverage data, analytics, visualization, and AI-supported outputs to enhance signal detection, aggregate safety review, and benefit-risk assessment.
- Perform medical coding checks, case series reviews, and standardize MedDRA search strategies.
- 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, including Safety Management Team (SMT) and Benefit-Risk Committee (BRC).
- The Safety Scientist contributes to proactive benefit-risk assessment and compliance with global safety reporting requirements.
Company info
- 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.
Equal opportunity
- If you require reasonable accommodation in completing your application, interviewing, or otherwise participating in the candidate selection process please contact us at hr.us@argenx.com.
- Only inquiries related to an accommodation request will receive a response.
This listing is sourced directly from argenx's careers page and normalized into a canonical job model.