Emily Jones

•5+ years of pharmaceutical industry experience as a Drug Safety Associate processing both clinical and post-marketing drugs•Performing triage, case processing and critically analyzing seriousness and expectedness •Processing, reviewing and submission of Individual Case Safety Reports (ICSR) for serious adverse events (SAE) and non-serious adverse events to Regulatory Authorities, IRB/ECs, and investigational sites in conformance with FDA and ICH guidelines •Preparing and reviewing NDA and MAA safety related documents•Generating and updating narratives ensuring quality, detail, clarity and consistency according to CIOMS template and Company’s Standard Operating Procedures as applicable•Performing Quality check of Adverse events, Serious Adverse events based on approved case processing metrics•Prioritizing QC review of cases•Determining the completeness of a case by generating queries to physicians and other healthcare professionals, consumers, affiliates, and co-marketers, by means of electronic mails, letters, telephone calls and faxes•Working effectively with focus and great attention using experience knowledge of US FDA, EMEA and ICH- GCP guidelines and regulations governing clinical trial safety environments•Excellent Medical Knowledge with expertise in the utilization of MedDRA for coding patient medical conditions and WHO-DD for drug coding•Working knowledge of global safety databases like ARISg, ARGUS along with working skills in Adobe Acrobat, Microsoft Windows /Office/ Word/Excel•Excellent managerial and communicational skills, zest to excel and perform beyond expectations •Team Player with commitment to work, under-taking responsibilities and fulfilling them efficiently