Perform ICSR Case Processing through the life cycle of the case from various sources such as Spontaneous, Literature, Regulatory and Clinical Trial. Case Type ➢ Perform quality review of the data entry done by associates which includes causality assessment, seriousness assessment, MedDRA coding for all the events, medical history, and laboratory findings, and narratives. ➢ Should have experience of reviewing cases using the triangle method. ➢ GVP Module ➢ Perform data entry related activities when required. ➢ Complete the case related activities within the stipulated time by prioritizing allocated cases in accordance to regulatory and service level agreement timelines and contribute to management of daily workflow. ➢ Review all follow-up information and identify relevant information and update the same in the safety database. ➢ Conducting peer review with a checklist to ensure 100% accuracy of adverse event data by immediate review of all cases. Categorize the errors as per the standard quality review measures. ➢ Provide feedbacks to the associates as appropriate. ➢ Analyze the trend of errors in particular project and assist the leads and managers to come up with a corrective action. ➢ Ensure timely and appropriate regulatory submissions. ➢ Identify the requirement and initiate deletions request, administrative edits, and addition of new code list terms and prepare deviation memos, to comply with guidelines and procedural documents. ➢ Participate in continuing awareness of company procedures and guidelines to maintain regulatory compliance. ➢ Participate in client projects, preparations for audits and inspections. ➢ Ensure compliance with company records retention policies. ➢ Complete all assigned trainings, both internal and client initiated within specified timelines. ➢ Participate in Process Improvement Initiatives to keep up the Quality and Compliance score. ➢ Ensure all activities are carried out in according to applicable control documents, and project requirement. ➢ The candidate is expected to have adaptability to different client case processing conventions and multi-task.
Job Types: Full-time, Regular / Permanent
Salary: ₹300,000.00 – ₹800,000.00 per year
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