Sharmila Banerjee

Responsibilities:

• Quality finalization of Individual Case Safety Reports (ICSRs), including spontaneous, literature, and other cases.
• Trained and mentored employees to maximize team performance.
• Perform case distribution to affiliates and submission of ICSR reports to applicable regulatory authorities through the Lifesphere Multivigilance (LSMV) database and EMA’s EudraVigilance portal.
• MLM screening: Screening on the EudraVigilance web portal, if trained and assigned.
• L2A monitoring: Performed L2A monitoring on the EudraVigilance portal in order to retrieve cases from the Competent Authority.
• Engaged in client meetings and cascaded important updates among the team members.
• Responsible for handling and reconciliation of mailbox.

Project Trainer.

• Conduct training, request database access, and expedite training compliance for the new hire.
• Addressing internal queries and client document requests.
• Conducting huddles and quality meetings with team members and providing real-time feedback to the case processor.

Database: Lifesphere Multivigilance (LSMV).

Responsibilities:

• Performed quality review of ICSR reports.
• Review data in the safety database to confirm that the case has been entered accurately from a medical and regulatory point of view, based on the source data provided. If any mistakes are identified during the quality check, the case should be returned to the data entry activity, and the mistakes can be corrected.
• Handled case intake, performed duplicate checks, and completed registration in Aris Global.
• Assessed AE case details to identify necessary actions in accordance with internal guidelines.
• Responsible for coding all medical history, events, drugs, procedures, indications, and laboratory tests according to the appropriate dictionary (e.g. MedDRA, Company Product Dictionary, and WHO Drug Dictionary.
• Executed submission and distribution activities.

Database: Aris Global.

Responsibilities:

• Case Processor and Quality Reviewer.
• Managed ICSRs received through data exchange system, ensuring compliance with SOPs and regulatory requirements.
• Ensured accuracy by reviewing and updating data capture fields, including reporter, patient, product, and adverse event details against source documents as per applicable guidelines and SOPs.
• Managed invalid report cases for pre-archiving in IRT.
• Analyzed error patterns and delivered insights to IRT case processor.
• Responsible for mentoring IRT case processors or IRT entry personnel as and when required.