Running pharmacovigilance across a global development program comes down to a series of decisions made under time pressure. Which safety events require expedited reporting, how to build a narrative that keeps the CSR accurate and complete, and how to maintain consistent medical judgment across cases, studies, and regions. Worldwide Flex pharmacovigilance services make those calls alongside your team and carry them through from Phase I development to post-approval. This includes end-to-end case processing for SAEs, AESIs, and other safety events, safety submissions direct to TGA, MHRA, EMA, and Health Canada, and post-approval support spanning PSURs, signal detection, and global literature surveillance. Because a named lead safety specialist is assigned to every project and team retention has held at 93%, consistent judgment carries across cases and studies—and because the team includes members with bedside nursing experience, the narratives that support your CSR hold up under regulatory scrutiny.
Read our fact sheet to learn more about our pharmacovigilance services, including:
