Department: Safety & Pharmacovigilance
Job Title: Specialist, Drug Safety & Pharmacovigilance
Description:
This position is responsible for the management of serious adverse events in oncology clinical trials including the collection, evaluation, collation and reporting of cases in accordance with global safety regulations, departmental standard operating procedures and company policies. This individual will perform verification of safety data, maintain case files and source documents, and prepare/QC serious adverse event narratives. This individual will have daily direct interactions with clinical trial sites and 3d party vendors in processing cases and will act as the liason for safety on multi-disciplinary teams, assisting in the development of study-related documents including protocols, CRFs and Investigator Brochures. Will also assist in implementation of safety database solution.
Job Requirements:
Growing Drug Safety department in support of oncology development programs seeks a qualified health professional to manage serious adverse events and other safety-related issues in accordance with global safety regulations in a fast-paced, team-oriented environment. Oncology experience; clinical trial safety experience; experience working with 3rd party vendors in overseeing outsourced safety-related functions; experience with safety. Health care background (or equivalent); a minimum of 2 years experience in drug safety within biotech/pharmaceutical industry.
