Clinical Safety Specialist (EU Remote)

Job description

Übersicht Selution, in partnership with Cordis, specializes in the development of ground-breaking technology and commercialization of advanced drug device combination products for the treatment of coronary and peripheral artery disease. Our mission is to revolutionize healthcare by creating next-generation solutions that address unmet and critical medical needs. Verantwortungsbereiche: This remote-based EU Clinical Safety Specialist monitors all safety aspects of our clinical research trial(s). With guidance, the Clinical Safety Specialist is responsible for collecting, assessing and processing Adverse Events (SAE) for safety reporting, CEC and DSMB across our clinical studies to ensure compliance with regulations and guidelines. Key Responsibilities: - Execution of Clinical Events Committee (CEC) and Data Safety Monitoring Board (DSMB): - Adheres to the study protocols and charters. - Provides reports and statistics related to dissemination of safety information to the clinical trial management team members and clinical trial core team members, as appropriate. - Monitors timelines for adverse event processing, reviews summary safety data at regular intervals and monitors CEC adjud...