Khandu Chadar

About Khandu Chadar

1) Clinical Trials cases – CT case creation, triage, and processing as per convention, like checking ASL and Protocol AESI. Working as the CTV/SDQC Designee/Case Processor, which helps in the reconciliation of the data that is received in the workflow and verify data or not miss any reporting of adverse events to the regulatory department within the timeline. It also helps in priority tracking cases.2) Software – Aris-G and LSMV3) Accountable for handling ICSRs and disposition of valid items from IRT to ARISg for further processing. 4) Responsible for generating and forwarding appropriate queries and requests for clarification of discrepant data or additional data.5) Identifying duplicate/invalid ICSR in ARISg and handling as per relevant SOP.6) Clinical trial assessments, which include case seriousness.7) Assuring and maintaining compliance with regulatory and local/global SOP timelines using proactive workflow management. 8) Team SPOC for the clinical trials cases and to maintain different trackers.9) Handled the quality reviewer’s position, in which performed quality checks of ICSRs processed by the case processor for accuracy and completeness. Performing a medical cohesiveness check in which accuracy and completeness of a narrative for its medical sense are checked.9) Experience of processing more than ICSR and disposition of more than 1500 ICSR from IRT to ARISg, which includes solicited and unsolicited.10) Part of the Access projects, completed the projects with excellent teamwork before the timeline given by the client with more than 98 percent of quality and compliance (well appreciated by the client).11) Received the best performer award from the project Lead for extra efforts towards process improvement with respect to quality.12) Hands-on experience of ICSR processing in the ARISg safety database.

Experience

1. Drug Safety Specialist

   Tata Consultancy Services

   May 2020 — Present · Thane, IN

   Hi Sir/Mam,I am khandu chadar. I have experience more than 2 years. I am working in tcs last 2 year. before that I had worked in NextGen Pharma In Pune for 6 Month as Quality Control Pharmacist.CT case creation, triage, processing as per convention like checking ASLand Protocol AESI. Working as the CTV/SDQC Designee which helps in the reconciliation of thedata which received in the workflow and verify data or not miss any reporting of adverse event tothe regulatory department within timeline. Also helps in priority tracking cases.

Education

• Dr. D Y Patil IPSR Pimpri Pune

  Post Graduation, Pharmacy

• Jeevan Pragati Vidhyalay, Nandur (Ghat) Taq. Kaij Dist. Beed

  Dr D Y Patil College of Pharmacy, Akurdi, Pune, Pharmacy

  2004 — 2012

• Savitribai Phule Pune University

  Bachelor of Pharmacy - BPharm, Pharmacy

• Jeevan Pragati Vidhyalay Nandur Ghat

  Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune, Pharmacy

  2014 — 2017

• Sojar College of Pharmacy Khandvi Barshi

  diploma in pharmacy, Pharmacy

  2012 — 2014

• Dr. D. Y. Patil Institute of Technology, Pimpri, Pune

  master, Pharmacy