Safety Scientist

This is a fully remote position, open to applicants in United States.

📋 Description

• Perform ongoing review and analysis of aggregated safety data from clinical trials, post-marketing individual case safety reports (ICSRs), literature, registries, and external databases.

• Detect data, analytical, or process enhancements that improve the chances of identifying a signal or reduce the time required for signal detection.

• Utilize data, analytics, visualization, and AI-supported outputs to boost signal detection, aggregate safety review, and benefit-risk assessments.

• Thoroughly review and interpret results from safety databases, analytics, and AI-enabled tools, applying sound scientific judgment along with an understanding of data limitations, bias, and confounding factors.

• Assist in the design, testing, and ongoing enhancement of data-driven and automated safety-surveillance workflows, ensuring compliance with quality, validation, and regulatory standards.

• Collaborate with safety physician team members to identify opportunities to enhance understanding of patient treatments, medications and interactions, and treatment pathways that inform actions and decisions for the safe utilization of argenx medicines.

• Conduct medical coding checks, case series reviews, and standardize MedDRA search strategies.

• Establish data acquisition strategies, methodologies, and approaches for safety evaluations.

• Aid in the assessment and management of medical safety data, and in the development and execution of safety signal and benefit-risk management strategies.

• Engage in analysis and actively participate in safety governance meetings.

• Lead and contribute to 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 disciplines.

• At least 5-7 years of experience in pharmacovigilance/safety risk management.

• Experience with quantitative or real-world safety data, preferably in signal-detection or benefit-risk analytics; a background in statistics or epidemiology is advantageous.

• Proficiency in utilizing GenAI or analytics tools to aid in the drafting of safety documents and data exploration.

• Familiarity with structured, reproducible, and traceable analysis workflows that support transparent and auditable safety analyses is a plus.

• Understanding of pharmacovigilance as it pertains to safety signal management and safety data review in both clinical and post-marketing environments.

• Capability to compile, analyze, and disseminate insights gathered from diverse data sources to inform benefit-risk decision-making.

• Strong communication skills to convey complex issues effectively.

• Ability to influence and collaborate with interdisciplinary teams.

• Proficiency in written and spoken English.

🏝️ Benefits

• Comprehensive benefits package.

• Retirement savings plans.

• Health benefits.