Summary
Overview
Work History
Education
Skills
Certification
Personal Competencies
Publications
Projects
Disclaimer
Timeline
Generic

B.Kranthi Kumar

Hyderabad

Summary

To work in a globally competitive environment and to utilize my skills and abilities on challenging assignments for contributing towards realizing the vision of the company and myself improvement.

Overview

7
7
years of professional experience
1
1
Certification

Work History

DRUG SAFETY ASSOCIATE II

PAREXEL INTERNATIONAL SERVICES PVT LTD
02.2022 - 04.2024
  • Drafted ARISg and ARGUS database
  • Developed triage of incoming reports for completeness, legibility, and validity, including literature abstracts/articles/citations
  • Drafting the documents and writing the Narrative as per the chronology
  • Working on atopic dermatitis, Anti ulcers drugs
  • Creates the case on the safety database
  • Monitoring and drafting Clinical Trial Sites to make sure that ICH, GCP guidelines, study protocol and applicable regulations are being followed
  • Reporting the adverse event forms
  • Ensures that the expectedness, causality assessment and seriousness criteria are accurate for the events
  • Prepares ADR form/coversheet as required
  • Compares and analyses data provided by the affiliate with the data available on client application
  • Addition of new products/deletion of products withdrawn from the market/expired license/MAH transferred products on the client application tool
  • Performs clear and accurate data capture of cases in accordance with client conventions/guidelines and Standard Operating Procedures (SOPs)
  • Generation, reporting and reconciliation of compliance metrics in collaboration with internal and external partners and stakeholders, where applicable
  • Mailbox handling for the respected project
  • ICSR case management
  • Reconciliation for the case processing data
  • Literature screening.

Drug Safety Associate

IQVIA
01.2021 - 09.2021
  • Worked as Drug Safety Associate (ICSR case processing, Data entry and Adverse event intake, Duplicate case searching) in IQVIA through Wissen infotech
  • Responsibilities Data entry of post-marketed Serious and/or non-serious individual case safety reports ensuring compliance with client standard operating procedures (SOP) and work instructions
  • Worked on SAPPHIRE data base
  • Identify and select the cases from workflow, determining appropriate prioritization criteria and submission dates
  • Performing the LOG an DE activity fields
  • Worked on covid-vaccine
  • Authoring the case validation
  • Duplicate searching, with multiple combinations
  • Coding of suspect drugs, concomitant drugs, treatment drugs and previously prescribed drug using Company Drug Dictionary and WHO Drug Dictionary
  • Review the seriousness criteria of all the evets and upgrade the events listed in & quote; Always Serious Lists quote, following the guidelines
  • Verify the data entered cases for accuracy, consistency and compliance with process requirements Use MEDRA to code Adverse Events, indications of Suspect and Concomitant medications, Medical History and Laboratory investigations.

Contract Research Associate

Hire Talentz (Axis clinicals)
06.2017 - 02.2020
  • Worked as Contract Research Associate at Hire Talentz (Axis clinicals), Miyapur X- Roads
  • Monitoring Clinical Trial Sites to make sure that ICH, GCP guidelines, study protocol and applicable regulations are being followed
  • Reporting the adverse event forms
  • Writing the forms as per the sponsor assisted documents
  • Worked on drugs Metformin, Anti epilepsy drugs, Anti-bacterial
  • Ensuring that only qualified staff and that they are adequately trained
  • Ensuring that data collected is accurate and verifiable
  • Managing the whole study by, ensuring the site has acceptable with good infrastructure and that it continuous to remain so throughout the study
  • And maintaining the appropriate filing of study documents and archival.

Education

M.PHARMACY (pharmaceutics) -

Malla Reddy College of Pharmacy, Osmania University

B.PHARMACY -

Vishnu Institute Of Pharmaceutical Education And Research, JNTUH

INTERMEDIATE -

Narayana Junior College, Kukatpally, State Board
01.2013

S.S.C -

New Era high school, State Board
01.2010

Skills

  • Jasper Reports
  • Aggregate Reporting
  • PSUR, PBRER, PADER, & DSUR
  • Reconciliation
  • Jasper and Sapphire Database
  • MedDRA coding
  • Data entry
  • Narrative writing
  • Literature Review
  • Clinical site monitoring
  • Analysing the documents
  • Review Article writing
  • Good communication skill

Certification

Certified aggregate reporting, PSUR, PBRER, PADER.

Personal Competencies

  • Good Communication Skills And Willingness to learn.
  • Friendly With an upbeat attitude.
  • Honest and Sincere With a High level of integrity.
  • Self confidence.

Publications

Development and Evaluation of Mucoadhesive Buccal Tablet of Valstartan published in world journal of pharmacy and pharmaceutical sciences vol (8), issue (11), 2019.

Projects

Industrial training program at Startech labs Pvt Ltd. Formulation and in-vitro evaluation of tablet in tablet formulation containing Hydrochlorothiazide and Eprosartan. Development and Evaluation of Mucoadhesive Buccal Tablet of Valstartan.

Disclaimer

I hereby declare that all the information given above is true the best of my knowledge.

Timeline

DRUG SAFETY ASSOCIATE II

PAREXEL INTERNATIONAL SERVICES PVT LTD
02.2022 - 04.2024

Drug Safety Associate

IQVIA
01.2021 - 09.2021

Contract Research Associate

Hire Talentz (Axis clinicals)
06.2017 - 02.2020

M.PHARMACY (pharmaceutics) -

Malla Reddy College of Pharmacy, Osmania University

B.PHARMACY -

Vishnu Institute Of Pharmaceutical Education And Research, JNTUH

INTERMEDIATE -

Narayana Junior College, Kukatpally, State Board

S.S.C -

New Era high school, State Board

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