AKASH SINGH

• Performed end-to-end case processing of Individual Case Safety Reports (ICSRs) from spontaneous and literature sources.
• Used Argus Safety to input, code (MedDRA), and evaluate adverse events.
• Handled Clinical Trial (CT) safety cases, including blinded and unblinded cases, ensuring accurate data entry, MedDRA coding, causality assessment, and timely SAE reporting in compliance with ICH-GCP guidelines.
• Maintained compliance with global regulatory timelines.

Global Pharmacovigilance mailbox handling:

• Responsible for assessing and routing communications to appropriate stakeholders received by the mailbox.
• Responsible for triaging adverse event reports including clinical trial
  serious adverse events and routing it for case processing activities.

Other Global PV operational activities:

• Maintenance of up-to-date Clinical SAE (Glenmark and Ichnos)
  tracker Clinical Study Master List for all Glenmark studies.
• Coordinate with Regulatory team for product label request for case
  processing.

Global literature:

• Maintenance of MA submission List for EU and GCC region.
• Annotate literature searches received from Ovid database.