Naresh Babu Thatikunta

About Naresh Babu Thatikunta

As per relevant Client SOP and conventions defined perform end to end data entry of the case in the Global Safety Database based on the information available in the source document.Perform In-line quality checks on serious and non-serious cases entered in Global Safety database in ordinance with applicable Client SOP and guidelines.Perform quality checks with reference to the agreed quality parameters and provide feedback to the team members for findings, ensure the corrections have been performed and documented the results.Analyze the errors in serious and non-serious case processing, identify the root cause, formulate and implement corrective and preventive action.Provide feedback to the individuals and the team on the results of the quality checks and ensure implementation of CAPA for the errors identified.Coordinate the quality assurance team in a timely closure of SLA QC findings.Ensure WHO Drug Dictionary and MedDRA coding as per Client SOP.For any reason, if the case had to be downgraded or upgraded during the case processing, action as defined in the Client SOP, guidelines.Complete and review the evaluation of the case including reporter/company causality, the narrative section and E2B sender’s comment field as per Client SOP.Route the case to the next step for In-line QC or Distribution.Perform case correction as per the guidance provided by the correction officer within the applicable timeline.Initiate and handle case suppression/ nullification as appropriate.Identifying new events, Medication errors, Lack of efficacy, Product quality issues, off- label use as per the client conventions and notifying the sender of the case.Assessment of expectedness/listedness of the reported events with the help of RSI documents(CCDS, EU SmPC, USPI, and IB).Responsible for maintaining the quality of processed case and meeting timelines.Maintenance of MOMs related to case processing and QC feedbacks.

Experience

1. Assistant Manager

   Aurobindo Pharma USA, Inc.

   Jan 2017 — Present · Hyderabad, IN

   Pharmacovigilance professional with more than 7 Years’ exclusive experience of working on PBRERs, PSURs, CASRs, ACOs, Signal reports, Submission Review of the summary reports, Project co-ordination, Quality Review of ICSR (spontaneous, literature, regulatory authority, clinical trial cases), Submission, Training, Mentoring. Hands-on databases Argus.

Education

• Sree Siddaganga College of Pharmacy

  M.pharmacy

  2011 — 2013