Dr. Vijay Y, MD, Fellowship In Pediatrics (FiP)

Experience

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  BALAJI NURSING HOME

  Jan 2008 - Jan 2010

  DMO
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  GENPACT

  Apr 2009 - Aug 2009

  Visiting Physician
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  OSMANIA MEDICAL COLLEGE

  Jan 2010 - Jan 2013

  POST GRADUATE STUDENT

  DID MY MASTERS DEGREE IN M.D PHARMACOLOGY AT OSMANIA MEDICAL COLLEGE.

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  QPS BIOSERVE INDIA PRIVATE LIMITED

  Aug 2011 - Jan 2014

  SUB INVESTIGATOR

  Preparation and review of SOPs-Supervision of dispensing and retention of Investigational Products-Training subordinates in ICH GCP and other relevant guidelines for proper conduct of the study-Providing Protocol training to the study personnel and delegation of job responsibilitiesOversee the Clinical Phase of a study from obtaining written informed consent from subjects and check-in, till check-out of the subjects as well as ambulatory samplings-Review the final report in coordination with all the concerned units. Show less

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  Government Medical College

  Jan 2014 - Oct 2014

  Senior Resident
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  Orakris Med Solutions

  Jan 2014 - Jan 2015

  Freelance Medical Writer

  Preparing Slide decks for :CME presentationsNational and International conferences

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  Bhaskar Medical College

  Oct 2014 - Jun 2016

  Assistant Professor
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  QPS BIOSERVE INDIA PRIVATE LIMITED

  Jan 2015 - Feb 2019

  Member, Ethics Committee
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  Vigi Medsafe Private Limited

  Jul 2016 - Jan 2019

  Pharmacovigilance Physician
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  Biological E. Limited

  Jan 2019 - now

  Clinical Trial• Prepare/ support in the preparation of the submission dossiers for health authorities (including Protocol, IB and other documents)- Preparation of Clinical Development Plan. • Assist the Clinical Operations team for planning and execution of clinical studies, monitoring and conducting the clinical development operation activities and resolving complex issues with respect to conduct of clinical trials in order to ensure generation of quality data for product approval.• Organise Data Safety review meetings• Due-diligence of all in-licensing dossiers. • Lead the team for preparation of Clinical documents such as rationales, justifications, waivers.Pharmacovigilance• Initiation and development of all drug safety reporting activities for marketed Vaccines in the Firm’s portfolio.• Causality assessments for safety reports.• MedDRA coding assessments and confirmations.• Literature article assessments for safety of the Vaccines of Firm’s portfolio and presenting the same on a monthly basis in the R&D meet.• Simultaneously managing the Pharmacovigilance aspects of many trials at different stages of development.• Ensuring the safety reporting systems proposed in protocols are appropriate for the phase of the trial.• Developing the SAE form completion guidelines for the clinical trials to provide detailed guidance on completion of SAE reports for the hospital sites participating in the trial.• Prepare responses to internal safety requests and contribution to responses to external safety queries. Act as Subject Matter Expert (SME) for Medical Operations/ Medical Function (participation in initiatives).• Maintaining a diligent awareness of potential regulatory changes as well as expert understanding of the impact of changing legislation associated with GCP, regulatory inspection outcomes and pharmacovigilance in clinical trials.• Standard Operating Procedure (SOP) creation and review. Show less

  • Assistant General Manager

    Apr 2022 - now

  • Senior Manager

    Jan 2019 - Jul 2022