Drug Safety Specialist

The Drug Safety Specialist will be responsible for processing serious adverse events in oncology clinical trials, focusing on the evaluation and reporting of cases in accordance with global safety regulations, departmental standard operating procedures and company policies. <br/><br/>The associate will track cases from receipt to closure, perform verification of safety data and will utilize clinical/pharmacovigilance judgement in coding of serious events and synthesizing complex clinical information into accurate and complete narratives. <br/><br/>The professional will also maintain accurate and audit-ready files and will interact daily with third-party vendors in the processing of initial and follow-up information on serious adverse events. <br/><br/>The qualified person will represent Drug Safety and Pharmacovigilance on assigned study teams and will contribute to the development and review of study-related documents including protocols, investigator brochures, informed consents, case report forms, and clinical study reports. In conjunction with the Drug Safety and Medical teams, the associate will perform safety review of accumulated safety data from phase I and II clinical trials and assist in the development and maintenance of accurate risk profiles for products in development. <br/><br/>Specialist will also collaborate daily with Drug Safety colleagues in the development and implementation of effective business processes that maximize efficiency and optimize pharmacovigilance principles.<br/>

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