Job description

Receipt of cases and their assessment to ensure the information is adequate to qualify the case as ICSR. Follow up for the information of potential cases as per SOPs if the initial information is inadequate. To provide periodic quality improvement feedback to case processors To identify areas of improvement in terms of compliance, quality, and productivity To review the cases for reporting assessment. x Provide product configuration request for Argus. To handle CAPA, deviation, change request and other QMS related activities. To provide MLM search result and ICSR Excel to vendor. To provide L2A (XML) Files to IT from Eudravigilance.

Skills Required

Key Skills

• QUALITY
• MEDDRA CODING
• NARRATIVE
• ARGUS
• ICSR
• QMS
• CAPA

Other Information