Ten years of concrete experience in Drug Safety / Pharmacovigilance and 3 years experience in clinical practice.Monitors the clinical safety signals of assigned projects/products in the Empirica Tool and available Health Authority databases (Oracle Argus Safety, ARISg). Expert in writing and reviewing safety sections of aggregate reports (PBRERs, PADERs, DSURs), drafting response to regulatory questions, analyzing data for possible signals (signal detection).Analyze, evaluate and interpret single case and aggregate adverse event data. Assessing seriousness, expectedness and comparing causality and querying for additional medical information needed to understand the event and determine causality .Trained/Mentored with MedDRA. Proficiency in medical terminology and ability to summarize medical information. Expert in triaging of incoming cases, data entry and narrative writingTrained in the field of PV including ICH GCP guidelines, MedDRA dictionary, various GVP modules and reference safety information documents. Additional responsibilities include training and evaluating drug safety associates and specialists