Senior Drug Safety Associate, Pharmacovigilance
Current• I have 2 Years of experience of working in Drug Safety Domain by performing Local Review and data entry of Non-Interventional cases, EDP cases, Product Quality Complaints cases and spontaneous adverse event reports.• Verify if the case meets criteria to be valid or invalid and split cases as needed, after consultation with the DSU. Documents seriousness as per instructions in standard operating process (SOPs)/ARGUS user reference guide (AURG) appropriately, when available and record whether the case is medically confirmed. Resolve validation warnings.• Set action item to notify the manufacturer of other company product, as appropriate.• Complete case data entry verbatim from source document.• Initiate appropriate follow-up activities (e.g. follow-up letter, action item special follow-up data, Data Capture Aid (DCA)/Safety targeted questionnaire (STQ) as per company specific documents. DCA/STQ letters with appropriate follow-up questions and/or questionnaires must be generated, when applicable.• Ensure all appropriate action has been completed (e.g., other manufacturer notification, non-assessed letter, License Partner (LP), forwarding to PQC Group, litigation intake and refund request).• Verify the accuracy and consistency of the data entered against the source documents and ensure data consistency between free texts entered in the narrative and all structured case form fields.• Document key activities performed at this workflow state in a case note in the Contact Log.• Provide Root Cause Analysis and Corrective and Preventive Analysis for client error or as and when asked.• Issuing queries and follow-up letter for missing data, clarification of illegible or discrepant data, or for requesting additional safety data to complete the case medically complete like concurrent conditions and other contributing factors and Translations of foreign language documents, if absolutely necessary.
