Profile Details

Create Project

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USD 25 /hr

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Hire Dr. Divya S.

United States

USD 25 /hr

Drug Safety Specialist | Regulatory Affairs Specialist | Clinical Research Associate with 7+ years of experience

Profile Summary

I have experience in regulatory affairs, pharmacovigilance, and clinical research, supporting global drug development programs from early development through clinical trials. My work includes regulatory gap analysis, IND-enabling documentation support, safety case processing, MedDRA coding, narrative writing, and preparation of submission-ready regulatory documents aligned with FDA, EMA, and ICH guidelines. I am experienced with safety and regulatory systems including Oracle Argus, Veeva Vault, SAP, TVT tools, and eCTD submission frameworks. My background enables me to support regulatory strategy, clinical documentation management, and safety compliance while ensuring data integrity, regulatory readiness, and well-structured documentation for successful clinical development and submissions.

Subject Matter Expertise

• ★ Drug Development
• ★ Pharmacovigilance/Drug Safety Monitoring
• ★ Regulatory Affairs
• ☆ Preclinical Research
• ☆ Clinical Trials

Services

• Writing

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing

Work Experience

Global Regulatory Affairs Specialist

Sandoz

August 2022 - June 2025

Drug Safety Specialist

PPD

February 2021 - July 2022

Student intern

RVM Institute of Medical Sciences

June 2018 - June 2020

Education

PharmD (Doctor of Pharmacy)

JNTUH College of Pharmaceutical Sciences

June 2014 - June 2020

Certifications

• Registered Pharmacist

  Telangana State Pharmacy Council (TSPC)

  January 2020 - Present