Extensive Work experience on safety case processing (Spontaneous, Clinical trials and literature) Safety Narrative writing, Assessment of seriousness, Expectedness/labelling of Adverse Events, Query Management, Dossier Preparation. Supporting regulatory submission to the authorities, ethics committees and institutional review boards. Exposure to Eudravigilance database. Responsible for coding all medical history, events, drugs, procedures, indications and laboratory tests according to the appropriate dictionary (MedDRA, WHO DD) Real time working experience on ARGUS, ARISg, Trace data base which has used for reporting of adverse event reports. Writing medical narratives for clinical study reports. Literature articles review and writing a summary narrative with all significant safety information published. Good understanding of the clinical development process, including basic knowledge of regulatory procedures with safety experience. Ability to self-organize, coordinate and prioritize activities across several parallel projects.