I have more than 7.5 years of experience in clinical research industry. My experience includes, but not limited to, preparation of regulatory documents including PBRERs/PSURs, Addendum to PBRER/PSUR; reports originating from signal detection and evaluation activities including Ad hoc reports, product quality complaints/HHE reports, Labelling justification documents, Contribution documents, Risk Management Plan in accordance with client requirements and conventions. - Have coded Individual Case Safety Reports (ICSRs) of all case types (spontaneous, clinical studies, and solicited programs), which includes triage, initiation of ICSRs into the safety database and conducting duplicate searches prior to initiation and identifying potential duplicates; and data entry of ICSRs in the safety database, including determining the expectedness of adverse events against various labeling documents (such as SPC, IB etc.), writing case summaries, assessing causalities if required and writing CIOMS comments if required. - Conducting quality review of regulatory documents and ICSRs - I also bring to the table strong computer proficiencies in MS Word, MS Excel and AWARE/SCEPTRE/ARGUS/ARIS G database. - Expertise in MedDRA coding in accordance with “MedDRA Term Selection: Points to Consider”. - Good working knowledge of the data entry conventions and guidelines, and International drug safety regulations including - ICH guidelines on safety and efficacy, Volume 9A/New PV legislation, US FDA guidelines and CIOMS.