Mansi Patel

• Triaged ICSRs, Coded (special situation, discharge summary, clinical trial, NIS, NIP/MAP, spontaneous, E2B, Literature and SUSAR) cases into Arisg database, assessed drug-event causality and end to end case coding and data entry into the safety database.
• Maintained understanding and compliance with SOPs, Work Instructions, GCPs, ICH guidelines, project/program plans and the drug development process.
• Participated in audits and inspections.
• Assessed the information to be queried and followed up until information was obtained and queries were resolved.
• Prepared presentations for every meetings regarding knowledge update and review of ICSRs.
• Proofread narratives and preparing a format for a narrative writing.
• Coordination with the reconciliation team to match clinical and safety databases.
• Roles at TCS: Case processor, E2B Mentor and Quality reviewer.

· Established work priorities and directions independently with minimal input form Manager and Team Lead.

· Achieved Star Performer of the month award.

· Knowledge to monitor and track Serious Adverse Events, serious and non-serious adverse drug reactions, and other medically related project information.

· Identified case assessment related problems and reviewed reports.

• Interpreted prescription orders, dispensed medications, and counseled patients on drugs.
• Educated patients about possible drug interactions and gave special administration instructions.
• Maintained appropriate drug records and completed reports as necessary.

• Interpreted prescription orders, dispensed medications, and counseled patients on drugs.
• Educated patients about possible drug interactions and gave special administration instructions.
• Maintained appropriate drug records and completed reports as necessary.

• Interpreted prescription orders, dispensed medications, and counseled patients on drugs.
• Educated patients about possible drug interactions and gave special administration instructions.
• Maintained appropriate drug records and completed reports as necessary.
• Data entry of prescriptions and ordered medicines.