Safety Reporting Manager - IQVIA Biotech (Europe/UK, US or Mexico - Homebased)

An exciting opportunity to lead Safety Reporting activities in Europe/UK/US where you will be responsible for submission of expedited and periodic safety reports to applicable Competent Authorities (CA) and Central Ethics Committees (CEC), for clinical trials of investigational medicinal products (IMPs) or clinical investigations of Medical Devices (MDs) according to relevant regulatory requirements, tracking of submissions as applicable, providing input into the development of the Regulatory Management Plan (RMP)  project specific Safety Reporting Plans (SRP) as applicable, overseeing regional safety reporting vendors from a compliance perspective and providing safety reporting input into new proposals and contracts. The Safety Reporting Manager works with the Global Head of Regulatory Affairs, Clinical Operations, Safety Management, Project Managers and Clinical Trial Managers in execution of safety reporting activities for regulatory projects.

Suitable candidates will need significant experience with clinical trial safety reporting including EudraVigilance expertise/certification.
Line management experience is not required.
Suitable home office setup with stable broad band internet and undisturbed work environment during core hours is required, candidates from outside the US also need certain flexibility for global collaboration with US clients and teams if needed.

At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible – to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 67,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way. Learn more at jobs.iqvia.com.