Austin, TX – **_IQVIA Biotech is seeking a Safety Reporting Specialist (Home-Based):_** **BASIC FUNCTION:** Delivers global safety reporting services including expedited and periodic safety reporting to Competent Authorities (CA) and Central Ethics Committees (CEC), for investigational medicinal products (IMPs) and Medical Devices (MD) according to ICH-GCP guidelines, regulatory requirements and IQVIA Biotech Standard Operating Procedures (SOPs) and/or project specific procedures. Primary responsibilities… a high level of understanding of applicable safety reporting regulations (FDA and ICH guidance, GCP regulations, EU Directives, country specific requirements etc.).+ Assists in the maintenance of the safety reporting regulatory intelligence repository and informing the Safety Management team and project teams of any pertinent updates.+ Submits expedited and periodic safety reports to Sponsors, Competent Authorities and Ethics Committees as applicable according to IQVIA Biotech SOPs and the project…