Case Processing Associate

Key Responsibilities:

Duplicate Search:Conduct thorough duplicate searches to ensure accuracy and avoid case duplication.

Case Validity Assessment:Evaluate cases to confirm validity in line with defined criteria, including completeness and relevance of data.

Coding of Suspect Product:Accurately code suspect products using industry-standard dictionaries (e.g., CCD-ODD).

Event Coding and Seriousness Assessment:Perform MedDRA coding for adverse events.Assess and document the seriousness of cases as per regulatory guidelines.

Case Book-In Process:Process spontaneous, E2B, and literature cases, ensuring all essential data fields are completed.

Ensure adherence to company procedures and timelines for case book-in.

• Ensure timely and accurate data entry of ICSRs from various sources, such as literature, health authorities, clinical trials, spontaneous reports, etc.
• perform duplication checks for ICSRs to identify and resolve any duplicate entries in the system.
• Perform Peer Review and data reconciliation of ICSRs, such as verifying the data accuracy, completeness and consistency, resolving the data discrepancies, etc.
• Coordinate with other ICSR teams, PV functions, IT and external vendors to ensure effective and efficient data entry activities, such as maintaining the data entry guidelines, updating the data entry systems, resolving the data entry issues, etc.
• Monitor and report the data entry metrics and performance indicators, such as the number of ICSRs entered, the quality and timeliness of the data entry, the compliance rate, the productivity, etc.
• Identify and implement process improvements and best practices for data entry, such as optimizing the data entry process, standardizing the data entry formats, enhancing the quality checks, etc.
• Provide support for audits, inspections and CAPAs related to data entry, such as preparing the audit/inspection readiness, responding to the findings, implementing the corrective and preventive actions, etc.

Skills:

• Analytical and problem solving skills
• Able to perform database/literature search
• Excellent verbal/written communication skills
• Client focused approach to work

Qualification: B.Pharm/M.Pharm/Pharm D

Experience: 2 -7years