Likitha Adigopula

Responsibilities:

Book in:

• Performing and reviewing the case reports, and booking the cases in the Argus database, case reports included literature, regulatory, CIOMS cases, as per Standard Operating Procedures (SOPs)/Work Instructions (WIs).
• Identifying whether the information received is initial or follow-up report information by performing a duplicate search in the safety database.
• Monitoring all emails received at the drug safety mailbox on all working business days.

Data Entry:

• Responsible for data entry of individual case safety reports (all case report types) into the safety database.
• Review and evaluate AE case information to determine the required action based on the work instructions and SOPs.
• Process all cases as per prioritization, with defined quality and productivity, in order to meet the project SLAs/KPIs.
• Experience in performing end-to-end case processing of ICSR in order to meet regulatory timelines from spontaneous, literature, and regulatory cases for both serious and non-serious reports reportable to the USFDA and EMA/MHRA.
• I had very good quality and productivity in the project.
• Co-ordinate with other workflows as required.
• Results-oriented and prioritization abilities.

Quality Review:

• To process individual case safety reports.
• To route processed ICSR to the next workflow with quality.
• Responsible for checking the completeness and accuracy of the data entered in the various fields.
• Track and maintain quality metrics.
• Review all cases to meet timelines, as per prioritization, with defined quality and productivity, in order to meet the project SLAs/KPIs.
• Guiding the new hires as a mentor and serving as one of the SMEs for data entry activities for the team.
• Support leads, managers, and operational activities as needed.

Validation:

• To access literature, case reports with validity criteria, such as abstracts and full-text articles.
• Identifying cases as valid, invalid, and potentially valid.