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Plot No., Daffodil Apartment,
Above Hero Honda showroom,
Near Lal chowki, Kalyan w,
Mob. No. : /
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.
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
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.
QC, maintaining various project trackers for entire team and reporting
to Team Leader.
Periodic Safety Update Report PSUR, providing medical evaluation
comments CCC and submission to regulatory authorities as per
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
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.
QA department for issue of documents like SOPs, Forms, Log Book, Protocols,
CRF’s and ICF’s according to requirement
This shall include the
Procurement of controlled
documents from QA department
Reviewing the draft ICF Both Marathi and English
Reviewing the draft
Protocol, CRF and Report
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
eCTD document for various regulatory
Handling Data archival
system Soft as well as Hard Copy.
software and BA/BE documentation process.
Patient Screening & Registration process Biometric Technique.
Preparation of Study
Protocol, CRF, ICF and Final Study Report.
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 .
from R.C.Patel College of Pharmacy,Shirpur NMU Jalgoan rd
& th Year . %
from Jaihind. Junior College, Dhule Nashik Board . %
New English School , Jamner Nashik Board . %
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
The basic aim of the project work is to improve and maintain the quality
of Bioequivalence studies in Indian CR
work as a part of curriculum PGDPM on the topic “Contract Research
Organization as New Business Opportunity in India” at
Microsoft Office Microsoft Word, Microsoft Excel, Power Point, Internet
& other basics of Computer.
system software to generate eCRF.
LALITKUMAR NILKANTH G.
HERO HONDA SHOWROOM,
LAL CHOWKI, KALYAN W
Date of Birth :
status : SINGLE
ENGLISH, MARATHI, HINDI.
Blood Group :
O Rh positive
Passport No. :
will be provided uopn request
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
Mr. Lalitkumar N. G.