Prajakta Bhandarkar
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Prajakta Bhandarkar Email & Phone Number

Senior RA officer: Clinical Trial at Cliantha Research Limited
Location: Nagpur, Maharashtra, India 6 work roles 2 schools
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Current company
Cliantha Research Limited
Role
Senior RA officer: Clinical Trial
Location
Nagpur, Maharashtra, India
Company size
767 employees

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Prajakta Bhandarkar is listed as Senior RA officer: Clinical Trial at Cliantha Research Limited, a with 767 employees, based in Nagpur, Maharashtra, India. AeroLeads shows a matched LinkedIn profile for Prajakta Bhandarkar.

Prajakta Bhandarkar previously worked as RA officer at Cliantha Research Limited and Jr. Medical Writer at Mediclin Clinical Research. Prajakta Bhandarkar holds M Pharmacy, Pharmacology And Toxicology, Cgpa - 9.12 from Ses'S R.C.Patel Institute Of Pharmaceutical Education And Research, Shirpur, Dist Dhule.

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Cliantha Research Limited

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About Prajakta Bhandarkar

I’m a postgraduate in Pharmacy (Pharmacology) with a passion to start my career in Pharmacovigilance and available as an immediate joiner for the Drug Safety Associate role. I am fully equipped with relevant skills for the job of Drug Safety Associate and ability to work independently but guided by documented procedures, with appropriate support. My professional skills in Pharmacovigilance are: • Performing the review and evaluations of ICSR information for validity, seriousness, expectedness and causality assessment following standard Pharmacovigilance procedures and guidelines• Hands on experience in writing safety narratives for ICSRs from different sources like Spontaneous, Literature etc. • Hands on experience in processing 100+ ICSRs meeting the quality standards and timelines• knowledge about safety database ICSR processing with defined WORKFLOW including Duplicacy check, case Book-In, complete case entry • Good knowledge to perform MedDRA coding for medical history, events, drugs /procedures/indications and laboratory tests in ICSRs• Exposure to Global Pharmacovigilance activities and standards including ICH, GVP, 21 CFR, CIOMS etc. for developmental and/or marketed products.• Exposure to aggregate reporting in Pharmacovigilance including PSUR/PBRER, PADER, DSUR including processes, timelines and standards as per EU, US etc. • Exposure to signal generation and safety analysis activities• Exposure to Audits/Inspections along with Quality Management System In addition, I have excellent attention to details ability work effectively as part of a team and once given the opportunity will be a valuable asset to the organization.

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Prajakta Bhandarkar's current company

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Cliantha Research Limited
Cliantha Research Limited
Senior RA officer: Clinical Trial
ahmadabad, gujarat, india
Website
cliantha.in
Employees
767
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6 roles

Prajakta Bhandarkar work experience

A career timeline built from the work history available for this profile.

Jr. Medical Writer

Mediclin Clinical Research

Mumbai, Maharashtra, India

• Preparation of Phase III and Phase IV Protocol, synopsis for various therapeutic area such as Ophthalmology, Respiratory, Diabetes Mellitus, Pain, Antimicrobials, Cardiovascular and other specialties for India and global submissions.• Writing Dossier, CSR, IBs, ICD, CRF, CTD.• Preparation of essential documents.• Preparing SEC presentation, research articles, abstract, Narrative writing and other essential documents • Literature search, systemic review of data and its analysis so as to be up to date with latest breakthrough in the therapeutic area.• Working closely with physicians and senior scientists for study design and protocol development to influence the clinical pharmacology strategy in support of drug development.• Project assignment and timelines to CRA’s.

Oct 2022 - Jun 2023

Drug Safety Associate Trainee

Aci - A Pharmacovigilance Training Management Company

Mohali District, Punjab, India

• Thorough knowledge of Global Pharmacovigilance Regulations including ICH, GVP, 21 CFR etc Strong knowledge of pharmacovigilance terminologies and Understanding of drug safety and the drug development process• Safety Database processing with Case Intake, Duplicacy Check, and registration with completeness and accuracy of the data entered • Performing the review and evaluations of ICSR information for further action following standard Pharmacovigilance procedures and guidelines • Processing of ICSRs meeting the quality standards and timelines. • Assessment of case reports for seriousness, causality, and expectedness • Perform safety database ICSR processing with MedDRA coding and writing safety narratives • Responsible for writing medically relevant safety narratives of cases and checking the completeness and accuracy of the data entered in the various fields

Feb 2022 - Jul 2022

Student Intern

Park Benz Laboratories

Bhopal, Madhya Pradesh, India

Jul 2018 - Aug 2018

Student Intern

Scan Research Laboratories

Bhopal, Madhya Pradesh, India

Jun 2018 - Jul 2018
Team & coworkers

Colleagues at Cliantha Research Limited

Other employees you can reach at cliantha.in. View company contacts for 767 employees →

MJ Mukund Junnarkar Mukund Junnarkar Colleague at Cliantha Research LimitedAhmedabad, Gujarat, India View → SJ Shraddha Jadhav Shraddha Jadhav Colleague at Cliantha Research LimitedMississauga, Ontario, Canada View → SR Shiva Rajput Shiva Rajput Colleague at Cliantha Research LimitedGreater Toronto Area, Canada View → VP Vasant Patel Vasant Patel Colleague at Cliantha Research LimitedAhmedabad, Gujarat, India View → VB Vinod Boricha Vinod Boricha Colleague at Cliantha Research LimitedAhmedabad, Gujarat, India View → RA Rx Ajay Padmani Rx Ajay Padmani Colleague at Cliantha Research LimitedAhmedabad, Gujarat, India View → MM Mrunal Mahore Mrunal Mahore Colleague at Cliantha Research LimitedNagpur, Maharashtra, India View → AJ Arpit Joshi Arpit Joshi Colleague at Cliantha Research LimitedAhmedabad, Gujarat, India View → BS Barkha Sindhi Barkha Sindhi Colleague at Cliantha Research LimitedMahesana, Gujarat, India View → PW Prashant Watmode Prashant Watmode Colleague at Cliantha Research LimitedAhmedabad, Gujarat, India View →
2 education records

Prajakta Bhandarkar education

Bachelor'S Degree, Pharmacy

Hi- Tech College Of Pharmacy Chandrapur
FAQ

Frequently asked questions about Prajakta Bhandarkar

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What company does Prajakta Bhandarkar work for?

Prajakta Bhandarkar works for Cliantha Research Limited.

What is Prajakta Bhandarkar's role at Cliantha Research Limited?

Prajakta Bhandarkar is listed as Senior RA officer: Clinical Trial at Cliantha Research Limited.

Where is Prajakta Bhandarkar based?

Prajakta Bhandarkar is based in Nagpur, Maharashtra, India while working with Cliantha Research Limited.

What companies has Prajakta Bhandarkar worked for?

Prajakta Bhandarkar has worked for Cliantha Research Limited, Mediclin Clinical Research, Aci - A Pharmacovigilance Training Management Company, Park Benz Laboratories, and Scan Research Laboratories.

Who are Prajakta Bhandarkar's colleagues at Cliantha Research Limited?

Prajakta Bhandarkar's colleagues at Cliantha Research Limited include Mukund Junnarkar, Shraddha Jadhav, Shiva Rajput, Vasant Patel, and Vinod Boricha.

How can I contact Prajakta Bhandarkar?

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What schools did Prajakta Bhandarkar attend?

Prajakta Bhandarkar holds M Pharmacy, Pharmacology And Toxicology, Cgpa - 9.12 from Ses'S R.C.Patel Institute Of Pharmaceutical Education And Research, Shirpur, Dist Dhule.

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