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Required Skills & Experience- Experience with the life science and healthcare industry.- Knowledge of GxP, 21 CFR Part 11, Annex 11 and validation processes in a regulated environment.- Strong technical skills in configuration, and issue resolution
What the Associate II, Pharmacovigilance does at Worldwide Responsible for the collection, processing, evaluation and reporting of incoming Serious Adverse Event (SAE) data according to applicable regulatory guidelines/requirements, Worldwide Standard Operating Procedures (SOPs) and project specific instructions.