Job OverviewThe Operations Specialist 2 in Regulatory Reporting will be responsible for assessing Lifecycle Safety (LS) data for reportability to relevant authorities, including global safety reporting requirements such as EudraVigilance. The candidate will track reportable cases and ensure timely reporting to regulatory authorities, ethics committees, institutional review boards, investigators, and oversight groups in compliance with legislation. This role involves liaising with local IQVIA offices and various functional team members to facilitate expedited reporting and address project-related issues and successes. The candidate will generate status reports, provide project metrics to PV Solutions Lead, maintain oversight of case workflow, and identify resource gaps. Additionally, the candidate will assist LS management with Safety Management Plan (SMP) reviews and implement process efficiencies on projects.Essential FunctionsAssess 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.QualificationsBachelor'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.#J-18808-Ljbffr
