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<pre>Array ( [var] => cut_url ) </pre> Resume for LALIT G. for Pharmacist / Biotechnology & Pharmaceuticals in Mumbai, India. Search More Resumes for Pharmacist on Resumark.com #333I1FH9E
 

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Resume for LALIT G. for Pharmacist / Biotechnology & Pharmaceuticals in Mumbai, India




Occupation: Pharmacist Industry: Biotechnology & Pharmaceuticals
Country: India City: Mumbai
State: Maharashtra ZIP: 400098



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BIODATA 

LALITKUMAR N.G.

c/o R.S.G.

Plot No., Daffodil Apartment, 

Above Hero Honda showroom,

Near Lal chowki, Kalyan w,

Email:

Mob. No. : /  
 
 

OBJECTIVE:  

I am interested in exposing myself in developing the internal quality system which wills inbuilt quality for through each step to achieve knowledge and skills for organization goal.

WORK EXPERIENCE:

Working as Drug Safety Specialist Pharmacovigilance Division in Tata Consultancy Services TCS, Vikhroli Mumbai Jan to till date

  • Processing and reporting of AE/SAEs reports. Clinical and Spontaneous cases
  • Gathering relevant information from source documents and entering in safety database Advent / Sapphire.
  • Analyzing and evaluating individual cases and collecting, collating and reporting adverse event data and drafting narrative for each case.
  • Coding of Adverse Events, patient history, product indication, suspect and concomitant drugs using Medical dictionaries eg. MedDRA.
  • Conducting internal QC, maintaining various project trackers for entire team and reporting to Team Leader.
  • Preparation of Periodic Safety Update Report PSUR, providing medical evaluation comments CCC and submission to regulatory authorities as per timeline.
  • Worked as Internal Quality Monitor in Synapse Labs Pvt. Ltd. Pune Jan to Jan

  • Inspecting and Review clinical study activities online to ensure compliance to SOPs and Good clinical Practices GCP and Good Laboratory Practices GLP
  • Faced DCGI, UK Sponsors audit.
  • Preparing Training Schedule, coordinating with the trainees and trainer, conduct the training, evaluating and maintaining the training records.
  • Keep the accountability of Logbooks used in the laboratory and also archival of the same.
  • Coordinating with QA department for issue of documents like SOPs, Forms, Log Book, Protocols, CRF’s and ICF’s  according to requirement
  • This shall include the following:

  • Procurement of controlled documents from QA department
  • Maintaining the accountability records
  • Preparing & Reviewing the draft ICF Both Marathi and English
  • Reviewing the draft Protocol, CRF and Report
  • Preparing & Reviewing the draft SOPs
  • Reviewing the Project specific Raw data foe accuracy, completeness and internal consistency and compliance to SOPs, Protocol,ICFs and CRF
  • Compliance of essential documents before/during/ after study
  •  

    Worked as Research Associate in Raptim Research Ltd, Navi Mumbai Jul to Jan

  • Preparation of eCTD document for various regulatory authorities USFDA.
  • Handling Data archival system Soft as well as Hard Copy.
  • Handling LIMS software and BA/BE documentation process.
  • Handling online Patient Screening & Registration process Biometric Technique.
  • Preparation of Study Protocol, CRF, ICF and Final Study Report.
  • Recruitment Healthy volunteer.
  • Blood separation methods.
  • Attending investigator meetings.
  • EDUCATIONAL QUALIFICTION:  
  • M.Sc in CR Clinical Research from Institute of Clinical Research, India, Cranfield University UK . %
  • PG in Pharma Management from Institute of Clinical Research, India . %
  • B.Pharm from R.C.Patel College of Pharmacy,Shirpur NMU Jalgoan rd & th Year . %
  • H.S.C from Jaihind. Junior College, Dhule Nashik Board . %
  • S.S.C from New English School , Jamner Nashik Board . %
  • THESIS WORK

    My project work as a part of curriculum MS in CR on the topic “Better Monitoring and Improvement of quality in BA/BE trial in CRO” at ICRI, Cranfield University UK 

    Description:  The basic aim of the project work is to improve and maintain the quality of Bioequivalence studies in Indian CR

    My project work as a part of curriculum PGDPM on the topic “Contract Research Organization as New Business Opportunity in India” at ICRI 

    COMPUTER EXPERTISE 

  • Computer skills Microsoft Office Microsoft Word, Microsoft Excel, Power Point, Internet & other basics of Computer.
  • Handled LIMS system software to generate eCRF.
  •  

    PERSONAL PROFILE: 

    Name    : LALITKUMAR NILKANTH G. 

    Address : C/O R.S.G.

          PLOT NO.

          DAFFODIL APARTMENT,

          ABOVE HERO HONDA SHOWROOM,

          NEAR LAL CHOWKI, KALYAN W

          KALYANW, DIST.THANE.

    Date of Birth   : th Mar  

    Gender : MALE

    Marital status : SINGLE

    Language : ENGLISH, MARATHI, HINDI.

    Blood Group : O Rh positive

    Passport No. : G

    Email :

     

    Mobile No.    : /

    Notes: References will be provided uopn request 

    Declaration:       

          I hereby declare that the information given above is complete and correct to the best of my knowledge and belief. I understand that I am liable to lose my lien on the job, prior to or any time during employment, in the event of the above personal information being proved false or incorrect. 

                                                                              Mr. Lalitkumar N. G.

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