Summary
Overview
Work History
Education
Skills
Websites
Personal Information
Languages
Declaration
Timeline
Generic

Latha Ogoti

Amalapuram

Summary

A dedicated and detail-oriented Drug Safety Scientist with 6.5 years of experience in pharmacovigilance and 2 years of experience in Clinical research, seeking to contribute expertise in adverse event monitoring and risk management to a dynamic pharmaceutical research team committed to patient safety and regulatory compliance.

Overview

11
11
years of professional experience

Work History

Drug Safety Scientist

Accenture Solutions Pvt Ltd
Chennai
07.2021 - Current
  • Responsible for Data entry, MedDRA coding and labelling assessment of Adverse event in SUSAR cases
  • Review and QC all Patient documents pertaining to a case for errors, missing information, legibility
  • Perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs)
  • Checking I-Medidata and J-review for patient profile and all other details for accurate reporting
  • Preparing contextual statements and providing aggregate summaries of previously reported SUSAR’s
  • Plan, organize, and manage daily work to meet service level timelines and deliverables.

Drug Safety Associate

Accenture Solutions Pvt Ltd
Chennai
11.2017 - 06.2021
  • Perform case creation of spontaneous, clinical (interventional studies, non-interventional studies), E2b, Literature and Local market
  • Reviewing the source documents/case, Checking for follow-up or create a case with the minimal mandatory fields as per the SOPs
  • Review and QC all the forms and documents pertaining to a case for duplicates, irrelevant information, legibility and case splitting if needed.

Clinical Research Associate

Quest Life Sciences Pvt Ltd
Chennai
10.2013 - 08.2015
  • Screening of Volunteers for Clinical study.
  • Informed consent presentation to volunteer prior to the clinical trial.
  • Clinical Trial Management, Clinical Data management.
  • Institutional Ethics committee coordination in getting approval for the clinical trials and related documents.
  • Preparation, documentation and compilation of case report forms (CRF)
  • Preparation and Maintenance of Trial Master file (TMF).
  • Coordination with trail sponsor and regulator authorities in conducting BA/BE studies.
  • Reporting of adverse events occurred during the trial within the regulatory timelines.
  • Preparation of Clinical summary update reports and Study summary reports.

Education

Masters in Pharmacy – Pharmacy Practice -

Andhra University
08.2017

Skills

  • Pharmacovigilance Regulations
  • MedDRA coding
  • Labelling assessment
  • Reviewing patient documents
  • Standard Operating Procedures (SOPs)
  • I-Medidata and J-review
  • Aggregate summaries
  • Drug Safety Expertise
  • Data Management
  • Case creation

Personal Information

  • Date of Birth: 08/03/1992
  • Gender: Female

Languages

Telugu
First Language
English
Advanced (C1)
C1

Declaration

I am aware that my resume is a representation of my qualifications and suitability for the position I am applying for, and I am prepared to provide supporting documentation upon request.

Latha Ogoti

Chennai, India

Timeline

Drug Safety Scientist

Accenture Solutions Pvt Ltd
07.2021 - Current

Drug Safety Associate

Accenture Solutions Pvt Ltd
11.2017 - 06.2021

Clinical Research Associate

Quest Life Sciences Pvt Ltd
10.2013 - 08.2015

Masters in Pharmacy – Pharmacy Practice -

Andhra University

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