Operations Specialist 2, Regulatory Reporting

**Job Overview****Essential Functions**- Assess Lifecycle Safety data for reportability to relevant authorities, including EudraVigilance, and track reportable cases.- Report to regulatory authorities, ethics committees, institutional review boards, investigators, and oversight groups per legislation, within timelines, and in a format compatible with requirements.- Liaise with local IQVIA offices and relevant stakeholders to facilitate expedited reporting.- Perform quality control of safety data and ensure compliance with IQVIA high-quality standards.- Generate status reports, provide project metrics to PVS Leads, and assist LS management with Safety Management Plan (SMP) reviews.**Qualifications**- Bachelor's Degree in a scientific or healthcare discipline or allied life sciences required.- Up to 5 years of relevant experience, including up to 3 years of Pharmacovigilance experience required.- Advanced level of English- In-depth knowledge and understanding of applicable Safety Database, global, regional, and local clinical research regulatory requirements.- Excellent organizational skills, time management skills, attention to detail, and accuracy.- Proven ability to work independently, multi-task, meet strict deadlines, and manage competing priorities.LI-Remote