Drug Safety

Prepare human benefit/risk assessment reports. Successfully extract data from an existing relational database derived from the FDA's spontaneous reporting system databases (SRS and AERS) in support of new product registrations. Prepare narrative summaries of selected cases derived either from adverse experience reports or the literature. Represent drug safety evaluation on scientific affairs project team.

Generation, review and updating of adverse event reporting plans; randomization and reconciliation plans. Set-up and maintenance of project files, core process files and central safety files. Reporting of expeditable adverse events and endpoints to clients, regulatory authorities, ethics committees, investigators and project personnel, within study specified timelines.