Experience

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  Kokilaben Dhirubhai Ambani Hospital

  • Mumbai Area, India

  • Head- Medical Research Department

    • Jul 2018 - Jul 2021
    • Mumbai Area, India

    Managing Clinical Trials, Investigator Initiated Studies, Academic Studies, Institutional Ethics Committee (IEC) Clinical Trials, IEC- Academics ( DNB, Emergency, Fellows ), Scientific Research Committee and IEC- Stem Cell Research

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  Panexcell Clinical Labs Pvt Ltd

  • Navi Mumbai

  • Head- Clinical Operations

    • Oct 2015 - Jun 2018
    • Navi Mumbai

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  Synapse Labs Pvt. Ltd.

  • Pune

  • PI and Head Clinical

    • Feb 2014 - Oct 2015
    • Pune

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  Vimta Labs Ltd

  • Project Manager

    • Jan 2011 - Dec 2013

    Overall management of clinical trials, including coordinating project planning/start-up, maintenance and close-out activities as per the ICH-GCP guidelines and other regulatory authorities.Work closely with: Sponsor’s representatives and CRO personnel such as Head-Clinical Research , CRAs, CRCs, Quality Manager, Business Development, Project Management.Support clinical research (protocol, CRFs, IB, PIS/ICF, CSRs etc.) & medico-regulatory writing (CTDs, clinical expert reports, SAE report)services outsourced to CRO by sponsors.

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  MakroCare

  • Associate Director-Late Phase Department

    • May 2009 - Dec 2010

    Provide business management and clinical research expertise to the project teams. Lead,manage, mentor, and supports the Project Managers (PM's) to achieve the goals of delivering quality projects to clients and exceeding project margins. Attend client meetings as required to improve profitability, quality and/or client satisfaction.Ensure that clinical studies are implemented and completed to high quality standards within defined budgets and on time. Responsible for the operational management, administration, evaluation and delivery of projects, including appropriate allocation of resources.Initiate and maintain high level relationships with internal and external stakeholders for a smooth and proffessional conduct of studies.Support Late Phase group function to enhance delivery of observational, non-interventional,registry, peri-approval projects, PMS, phase IV.

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  Aizant Drug Research Solutions Pvt Ltd

  • Principal Investigator,Senior Manager

    • May 2008 - Apr 2009

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  Novartis

  • Medical Writer

    • Mar 2008 - May 2008

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  AUROBINDO PHARMA LTD

  • India
  • Pharmaceutical Manufacturing
  • 700 & Above Employee

  • Pharmacovigilance Deputy Manager

    • Aug 2007 - Mar 2008

    Worked as a Deputy Manager in Pharmacovigilance Department in Aurobindo Pharma.I used to report all the adverse events of our approved and marketed drugs every week to all the regulatory authorities in UK and U.S.I have prepared PSUR's for the drugs periodically,well versed with Medra coding,assessment ,seriousness of the adverse event.My email is [email protected].

  • Clinical Investigator

    • May 2004 - Jul 2007

    Worked as clinical investigator in aurobindo pharma,conducting more than 300 bioequivalence studies.I have faced FDA,WHO,MCC,EU and brazil Anvisa Audits. Iam well versed with ICH GCP,FDA,EU and other regulatory guidelines.

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  Vimta Labs Ltd

  • Medical Investigator

    • May 2002 - May 2004

    I worked as a medical investigator in vimta labs from April 2002 to May 2004,conducting more than 250 Bioequivalence studies and was responsible for its clinical part of the study which includes screening of volunteers,managing adverse events,preparing protocols and reports,IEC activities.I also have experience in monitoring BA/BE studies.