/ http://www.slideshare.net/images/logo.gif / ºÝºÝߣShare feed for ºÝºÝߣshows by User: ankursonkar1 https://cdn.slidesharecdn.com/profile-photo-ankursonkar1-48x48.jpg?cb=1580290875 Working knowledge of ICH Good Clinical Practices, FDA and EMEA investigational and post marketing regulatory guidelines. •Experience in writing aggregate reports like PSUR (now PBRER),PADER, ASR (now DSUR), SMR, Summary bridging, addendum reports etc, •Knowledge of Volume 9A (to be replaced by Good Pharmacovigilance Practices) and 10, New EU regulations, ICH E2C (R2). •Effective communication, organization and time management skills. •Ability to work independently under tight time constraints. Review, conduct analysis and write specific sections in order to draft the final version of aggregate safety report. (PSUR: Cyclical, Renewal, ASR, AR and SBR.) •Create all documents in ...