Working knowledge of ICH Good Clinical Practices, FDA and EMEA investigational and post marketing regulatory guidelines.
鈥xperience in writing aggregate reports like PSUR (now PBRER),PADER, ASR (now DSUR), SMR, Summary bridging, addendum reports etc,
鈥nowledge of Volume 9A (to be replaced by Good Pharmacovigilance Practices) and 10, New EU regulations, ICH E2C (R2).
鈥ffective communication, organization and time management skills.
鈥bility 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.)
鈥reate all documents in ...
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