Omprakash Nandedkar

Experience

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  Serum institute of india pune

  Dec 2010 - Jun 2011

  Project Trainee

  • Having a 6 months of Clinical Research experience with an investigator site. Well-versed with site assessment, site initiation and interim site visits as well as coordinating responsibilities at an investigator site like handling documents, drug accountability, EC submissions, etc.Possess good communication and problem solving skills with clinical research knowledge and application.Academic project on phase 4 ongoing clinical trial as a monitoring role.Seven months work experience on an ongoing trial of Nasovac vaccine at serum institute of India.• Patient recruitment• Review of source document and CRFs.• Handling drug accountability log• Handling subject visits• Working on Electronic Data Capture (EDC)• Completing CRFs/eCRFs• Subject screening & enrolment• Informed Consent Process• Site feasibility• Site initiation• Site Selection Visit• Follow up with site for patient recruitment• Interim monitoring visits• Financial and clinical trial agreements• Communication with CRO Show less

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  Cognizant Technology Solutions India Pvt. Ltd.

  Apr 2012 - Mar 2014

  Drug Safety Associate

  ICSR activityCase bookig/initiationCase validityDupliae searchData entry/case processing Causality assessmentNarative writing in medically cohesive mannerGenerated queries using ARGUS interface for clarification, resolving and forwarding to the next workflow and communicated to outside sources.

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  TCS

  Apr 2014 - Dec 2018

  Pharmacovigilance Scientist II

  ICSR SME7 Day SUSAR responsible Mentoring new case processorsQuality reviewer and internal QC check for SUSAR, Pregnancy casesSAE Reconciliation and vigilane on clinical and safety data bacee

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  TCS

  Jan 2020 - Jul 2022

  Business Process Lead

  Team management and get work done on timelines.Assigning daily work to team based on due dates.Team building activities and motivationExcellent decision making skills with a positive approachMultitasking, ability to sketch the plan and prioritize workWorking on achieving quality and productivity for teamGrooming Team LeadEmergency patient unblinding (Blind Break Lead and Witness)Well versed with safety databases like ARGUS and ARISg (ver 7.4.2.2)Effectively handled adoc projects within process as per regulatory requirementLegal cases reviewer Show less

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  Viatris

  Jul 2022 - now

  Assistant Manager