Praniti Dhumal

• Perform case processing and quality review of clinical trial, spontaneous, pregnancy, literature, MHRA and EVHUMAN cases and provide quality feedback to the team members.

• Perform triage and classify ICSRs for report type, seriousness, causality, labeling, and reporting; prioritize ICSRs according to regulatory requirements.

• Perform follow-up activities and send follow-up letters for cases.

• Perform exchange of cases.

• Prefilteration of EV, MLM, and MHRA cases.

• Provide training and support to junior pharmacovigilance associates.

• MedDRA and WHO coding

• Handled multiple projects with utmost quality.

• Provide support to other activities undertaken by the project team on behalf of the client and the company.

• Case processing and quality review of spontaneous, pregnancy, literature, MHRA, EVHUMAN and social media cases.
• Triage and classify ICSRs for report type, seriousness, causality, labeling, and reporting; prioritize ICSRs according to regulatory requirements.
• Completion of risk and quality (label, approval, and manual coding).
• Clarification of unclear or illegible information from the ICSR sender (i.e., local safety officer [LSO], or Call Center).
• Completion of the remaining case data entry, including narrative or auto-narrative.
• Prioritization of incoming cases for workflow management.

• Case processing of clinical trial, spontaneous, non-interventional studies, non-interventional programs, pregnancy, 07 Day SUSAR cases.
• Mentoring of new joiners
• Cross training of exiting associates on other case types
• Cross training of back to work associates (ex. Associates returning from long leave/ maternity leave)
• Taking session for entire Pune/&or Mumbai division for new update or new client requirement.
• Preparation of new training process.
• Case allocation and distribution.
• Accountable for handling ICSR files received via data exchange system disposition of valid items into case processing tool from receipt intake tool for further processing in ARISg.
• Acknowledging receipt of ICSR to sender, handling invalid items in IRT appropriately, identifying possible SUSAR and informing to hierarchy to maintain timeline. Processing of ICSR (Including SUSAR cases and special scenario cases) and accountable for sending queries related to information received.