Sai Sahruday Tadikonda

• Performed end to end literature screening process for identifying safety information by ensuring adherence to regulatory requirements and internal SOPs.
• Performed duplicate search and review of literature results into literature review system on a weekly basis for ICSR.
• Review of literature citations to determine for aggregate safety information in support of the periodic report and signal detection.
• Performed quality review of the citations after initial review for ICSR and new aggregate information.
• Ordering and maintaining track of full text articles.
• Raising, tracking and maintaining translation requests for the articles in local languages.
• Assigning screening tasks to team members based on workload and publication volume, monitoring day-to-day operations by ensuring optimal resource utilization.
• Tracking KPIs such as screening timelines, accuracy, number of articles reviewed, error rates and areas of errors for preparation of report to identify performance gaps and initiate improvement measures.
• Proper documentation and traceability of screened articles.
• Maintaining quality data of the team and conducting sessions for knowledge sharing to ensure quality improvement of the associates.
• Mentored and guided employees to foster proper completion of assigned duties.
• Assisted with new hire processing and existing training programs.
• Coordinated weekly meetings for internal and external groups.
• Mentoring and knowledge transfer to newly recruited associates to ensure continuous skill development of the team.
• Led root cause analysis (RCA) and implemented corrective and preventive actions (CAPA).
• Providing insights and timely updates of the team performance to the higher management.

Literature Screening

• Analyzed data to identify root causes of problems and recommend corrective actions.
• Collaborated with stakeholders to identify business needs and data sources.
• Performed literature review of articles for ICSR and aggregate reporting.
• Placed orders for the articles requiring full text and review of full text articles.
• Performed secondary/ quality review for the initial review done by other associates.
• Mentoring for newly recruited associates.
• Allocation of literature citations for initial review.

Individual case safety reports (ICSR)

• Performed triage, intake and book in for ICSR.
• Performed quality check of the ICSR cases processed by case processors.
• Provided training and mentoring to team members on book in, case processing and quality review in ICSR.
• Identifying skill gaps and organized refresher training sessions.
• Allocation and tracking of the ICSR cases according to the internal and regulatory timelines.
• Conducting root cause analysis and implementing corrective and preventive actions for late cases or timeline deviations.
• Monitored metrics like case turnaround time (TAT) and error rates.
• Coordinated with cross-functional teams like medical reviewers, quality teams and client representatives for the timely completion of cases.
• Tracking and reporting team performance using KPIs and SLAs.
• Attended client meetings and providing updates on the team performance and compliance.
• Supported audit and inspection and ensured documentation and records are well maintained handy for audit at all times.