Pharmacovigilance Associate
CurrentCreate and submit drug specific adverse events/product complaint reports following FDA regulations. Conduct quality check and reconciliation of information, spelling, drug, manufacturer, and grammar included in the notations. Identify AE’s through the daily QC process and report any missing AE’s or PC’s to clinician and ultimately to the manufacturer. Ensure that any identified missing reports have been submitted and accounted for. Communicating with clinicians regarding questions or concerns with the content or quality of AE reporting. Collaborate effectively and efficiently with team members as well as other departments.