Clinical Safety Analyst

Role: Clinical Safety Specialist focusing on worldwide surveillance of clinical trial patient safety data and process improvements. Responsibilities: timely assessment and review of safety data, contribution to safety reports, monitoring investigator queries, collaborating with medical monitors to plan safety reviews, and ensuring compliance with ICH, FDA, and EMA guidelines. Also involved in reviewing study protocols for safety language, safety data in clinical study reports, and creating narratives for serious adverse events. Qualifications: Bachelor's degree in health sciences; RN or clinical pharmacy background preferred. At least 2 years of clinical practice experience and 1 year in drug safety within clinical trial lifecycle (Pre-Phase I to market). Skills: proficiency in Windows, Word, Excel, clinical databases (e.g., Oracle, PIMS); strong medical data evaluation; effective communication. HighValue: Clinical safety surveillance in trials across phases, regulatory compliance, safety data review, and safety monitoring in line with global guidelines. WorkSetup: not specified; likely in a clinical or office setting.