Soumyajit Chakraborty

• Accurately collect and document all relevant information from adverse event reports, ensuring completeness and consistency.

• Enter adverse event data into the pharmacovigilance database in a timely manner, following company SOPs and regulatory guidelines.

• Perform initial and follow-up case processing, including narrative writing and coding of adverse events, using MedDRA terminology.

• Identify and escalate high-priority cases, including those involving serious or unexpected adverse events, to ensure expedited processing and reporting.

• Assess the seriousness of adverse events based on established criteria, including outcomes such as death, life-threatening conditions, hospitalisation, and significant disability.

• Evaluate the causal relationship between the drug and the adverse event, considering factors such as temporal association, de challenge/re challenge information, and alternative explanations.

• Ensure compliance with local and international pharmacovigilance regulations, including timely submission of serious adverse event reports to regulatory authorities.