Experienced healthcare professional with experience in pharmacology, drug safety and pharmacovigilance. Highly proficient in safety monitoring and adverse event reporting of both clinical trial and post marketed drugs.Proficient in using the Oracle Argus Safety database version 8.1.2. Proficient in using MedDRA coding and WHO Drug dictonary. Knowledge of 21 Code of Federal regulations, ICH, GCP guidelines, EMA regulations, GVP modules, HIPAA. Experience with detailed entry of ICSR in Oracle argus database including experience with XML files. Proficient in writing case narratives. Good experience with literature review and coding.Complete knowledge of all global regulatory requirements and their timelines.