Adverse Reaction Reporting Specialist
Current-Monitor department adherence and compliance regarding training with adverse reaction SOPs and other specific procedural documents (initial screening questionnaire, departmental responsibility flowchart)-Actively participate in quality investigations of adverse reactions and implementation of corrective & preventive actions.-Subject Matter Expert (SME) in charge of all adverse reaction reporting obligations based on pharmacy background. I conduct screening and follow-up of adverse… Show more -Monitor department adherence and compliance regarding training with adverse reaction SOPs and other specific procedural documents (initial screening questionnaire, departmental responsibility flowchart)-Actively participate in quality investigations of adverse reactions and implementation of corrective & preventive actions.-Subject Matter Expert (SME) in charge of all adverse reaction reporting obligations based on pharmacy background. I conduct screening and follow-up of adverse reactions, assess adverse reactions including causality assessment, and interpret clinical data and seriousness for purposes of expedited reporting to Health Canada.-Designed and implemented the Adverse Reaction Report program and the Product Recall Program through research and best practices. Introduced program to Production, Supply Chain and Quality Assurance.-I streamlined the program with customer service, regulatory, and quality assurance so ~10-13 reported cases of serious and non-serious adverse effects with products each month were assessed and resolved within 72 hours of initial contact with the customer. The 72-hour timeline was sustained despite multiple cases reported on the same day and were prioritized based on serious or non-serious and severity of the reaction.-I created and maintained a central adverse reaction master file for AR’s related to each product Show less