ARISg refers to a safety data management system used to capture, review, and track adverse event reports and related regulatory information. It is used in pharmacovigilance and product safety workflows to support case processing, data quality checks, and required reporting. The skill involves working with the system to enter information, monitor case status, and maintain compliant safety records.

Detection Theory refers to a framework used to understand and analyze decision-making processes in the presence of uncertainty. This skill encompasses the principles of signal detection, distinguishing between true signals and noise, and evaluating the accuracy of judgments made under uncertain conditions. Knowledge of Detection Theory is applied in various fields, including psychology, telecommunications, and medical diagnostics, to improve the reliability of detection systems and enhance decision-making strategies.

MedDRA (Medical Dictionary for Regulatory Activities) is a standardized medical terminology used to classify and analyze adverse events or medical conditions occurring in clinical trials or post-market surveillance. It simplifies the process of communication between different stakeholders in the pharmaceutical industry, including regulatory agencies, drug manufacturers, and healthcare providers. MedDRA terminology consists of over 80,000 medical terms, which are organized into a hierarchical structure and coded to facilitate data analysis and comparison across different studies and databases. Understanding and applying MedDRA terminology requires specialized skills and training in pharmacovigilance and regulatory affairs.

Pharmacovigilance refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. This skill encompasses the systematic monitoring of pharmaceutical products to ensure their safety and efficacy throughout their lifecycle. Knowledge of Pharmacovigilance is used to analyze data from clinical trials and post-marketing surveillance, facilitating informed decision-making regarding drug safety and regulatory compliance.

Postmarketing Surveillance refers to the process of monitoring the safety and effectiveness of a product, particularly pharmaceuticals and medical devices, after they have been released to the market. This skill involves the collection and analysis of data related to adverse events, product performance, and patient outcomes to identify potential risks and ensure ongoing compliance with regulatory standards. Knowledge of Postmarketing Surveillance is used to inform stakeholders about the long-term effects of products, guide risk management strategies, and support regulatory decision-making.