Summary
Overview
Work History
Education
Skills
Accomplishments
Internship
Languages
Disclaimer
Affiliations
Timeline
Generic
Nithyashree N

Nithyashree N

Sira

Summary

Accomplished Regulatory Toxicologist at Syngene International Limited, skilled in scientific report writing and regulatory compliance. Successfully authored critical nonclinical modules and ensured adherence to ICH guidelines, enhancing submission quality. Demonstrated effective communication and a continuous learning mindset, contributing to the advancement of drug safety assessments and regulatory submissions.

Overview

4
4
years of professional experience

Work History

Regulatory Toxicologist

Syngene International Limited
Bengaluru
08.2022 - Current
  • Executed literature searches and retrieved scientific data on pharmacological, pharmacokinetic, and toxicological endpoints.
  • Prepared reports on Permitted Daily Exposure, Acceptable Daily Intake, and Occupational Exposure Bands/Occupational Exposure Levels for APIs.
  • Authored nonclinical overview and summary modules for regulatory submissions.
  • Reviewed eCTD modules 2.4 and 2.6 for quality assurance prior to final submission.
  • Drafted safety data sheets for pharmaceutical products utilizing WERCS software.
  • Conducted in silico predictions of toxicological data using DEREK and CASE Ultra software.
  • Compiled ICH M7 reports for new drug entities to ensure compliance with guidelines.
  • Hands on experience on calculations of Reference Dose and Margin of Safety.
  • Familiar with OECD, ICH, and GLP guidelines.
  • Participated in preclinical studies as study personnel for biocompatibility (ISO 10993-11 and ISO 10993-12).

Consultant Doctor

08.2021 - 07.2022
  • Worked as a consultant doctor for small and large animals.

Education

M.V.Sc - Veterinary Pharmacology And Toxicology

Veterinary College
Bengaluru
01.2021

B.V.Sc & A.H -

Veterinary College
Bengaluru
01.2018

Skills

  • Animal handling techniques
  • Drug administration
  • Blood collection and analysis
  • Lyophilization and ultracentrifugation
  • Neuropharmacology studies
  • Effective communication
  • Animal facility management
  • Continuous learning mindset
  • Toxicity study design
  • Regulatory compliance
  • Scientific report writing
  • Report preparation

Accomplishments

  • Attended ISVPT conference, Thrissur, 2019, Evaluation of effect of halquinol on intestinal motility in rats.
  • Attended workshop, 'Ethical and welfare issues in animal usage in biomedical research', Veterinary College, Shivamogga

Internship

  • Institute of Animal Health & Veterinary Biologicals (IAH & VB), Bengaluru
  • Sri Chamarajendra Zoological Garden, Mysore
  • Clinical exposure of veterinary surgery, medicine, and gynaecology in various veterinary hospitals across Karnataka.
  • Central Poultry Development Organization and Training Institute (CPDO&TI)
  • State Livestock Breeding and Training Center (SLBTC), Hesaraghatta
  • Central Frozen Semen Production and Training Institute (CFSPTI), Hesaraghatta
  • Acquired skills in treating clinical cases of large & small animals in Teaching & City Hospital, Bangalore
  • DLJ piggery farm, Nanjangud
  • Practical experience in Disease diagnosis and Treatment of dairy cows in KMF routes such as Bangalore milk union

Languages

  • Kannada
  • English
  • Telugu
  • Hindi

Disclaimer

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

Affiliations

  • Published an article titled 'Nanocurcumin Restores Arsenic-Induced Disturbances in Neuropharmacological Activities in Wistar Rats' in the Toxicology Internal Journal

Timeline

Regulatory Toxicologist

Syngene International Limited
08.2022 - Current

Consultant Doctor

08.2021 - 07.2022

M.V.Sc - Veterinary Pharmacology And Toxicology

Veterinary College

B.V.Sc & A.H -

Veterinary College

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Nithyashree N