Rakesh Gadekar

About Rakesh Gadekar

A competent professional with 10.8 years of experience in Pharmacovigilance, Clinical Trial Disclosure, and Transparency, as well as Clinical Narrative Writing, currently working with Tata Consultancy Services Ltd. I have gained valuable experience working with multiple reputed clients and possess a strong understanding of the end-to-end processes in Pharmacovigilance, CTD, CSR-Narrative Writing, and Quality Review (CSR, IB,Protocol). Previously, I held positions as a Case Intake Officer, Case Processor (Patient Safety Narrative), Quality Reviewer, Submission Officer, and Subject Matter Expert.

Experience

1. Business Process Lead

   Tata Consultancy Services

   Jul 2018 — Present · Pune, IN

   Clinical Trial Disclosure and Transparency Draft new protocol registrations into Protocol Registration and Results System (PRS) within theClinicalTrials.gov and and EU PAS registry in accordance with 801 and the Final Rule. Quality Review of new protocol registrations to check if trial registrations are accurate, consistent with the protocol and other source data as per requirements. Communicate effectively with stakeholders to resolve comments. Update CTG Registration Activity. Obtain approval and release protocol records. Notify study team if protocol records are published on CT.gov without NIH QA comments. Address NIH QA comments as appropriate and resend for review. Update CTMS or Site management tool as needed. Keeps track of the study progress and updates it every day as needed. Support registration updates for ClinicalTrials.gov in compliance with 801 and the Final Rule. Monitor studies requiring routine updates using CTMS reports on a daily/weekly basis. Initiate Update Request Email to ClinOps team using D&T Emailer Tool. Update CTMS with \"Request Sent\" status for registration updates. Implement changes on CT.gov PRS based on feedback from ClinOps. Update internal tracker correctly on daily basis and share with external stakeholders on whenever needed. Quality Review of registration updates on daily basis to maintain its accuracy and consistency. Release record on CT.gov PRS after Study Director approval. Address NIH QA comments as necessary and resend for study team review. Worked on redactions as per 0070 policy, 0043 policy, Health Canada, EU CTR. Writing of Plain language protocol synopsis.

Education

• Savitribai Phule Pune University

  Master of Pharmacy

  2010 — 2012

Skills

• Pms Cases
• Triaging
• Icsr Processing
• Reg Db Review
• Pgd Review
• Blue Flag Analysis
• Ib Lebelling
• Eudravigilance
• Ich E2b Guidelines for Pv
• Study Unblinding
• Ich E2b
• Duplicate Check
• Arisg
• Case Deactivation
• Sop
• Triaging of Clinical Trial Cases
• Affiliate Case Acceptance
• Ich-Gcp
• Ade Master Sheet
• Medical Coding
• Database of Initial Case
• Gvp
• Case Assignment
• Suspected Case Labelling
• Literature Case
• Fu Resend
• Routing of Case to Mr
• Ich E2a Guidelines for Pv
• Case Correction
• All Substance List
• Offline Qc Tool Correction
• Ngx Labelling
• Online Qc Check of Ct Cases
• Sgd Review
• Meddra
• I Narrative
• Uspi Labelling
• Action Item Generation
• Qc Tool Corrections
• Narrative Writing