INTRODUCTION
Your role as a Quality Reviewer is to review the case quality in terms of structured entry of serious and non-serious adverse events onto the global pharmacovigilance safety database.
Your role will also include supporting the end-to-end processing of client requests across all areas and subsidiaries across the globe.
FUNCTION
• Verify that the Case Processor has entered incremental information from initial and follow-up reports into the global pharmacovigilance database
• Analyze the relevance of information extracted from routine source documents
• Evaluate event extraction accuracy
• Check the narratives against routine source documents
• Review all adverse event reports and assess their seriousness and causality
• A review of MedDRA and WHO-DD coding accuracy for reported adverse events, concomitant drugs (suspect, concomitant, historic; international nonproprietary name), and concurrent diseases in accordance with global coding guidelines
• Correct the case and route it to the next level
• Provide training and improvement initiatives based on observed QC issues
• Provide associates with timely feedback
REQUIREMENTS
• Degree in Life Science
• A minimum of 2 years’ pharmacovigilance experience is required
• Business English
