プロフィール詳細

プロジェクトを作成

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Dr. Divya S.に依頼

United States

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

プロフィール概要

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.

専門分野

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

サービス

• Writing

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

職務経験

Global Regulatory Affairs Specialist

Sandoz

8月 2022 - 6月 2025

Drug Safety Specialist

PPD

2月 2021 - 7月 2022

Student intern

RVM Institute of Medical Sciences

6月 2018 - 6月 2020

学歴

PharmD (Doctor of Pharmacy)

JNTUH College of Pharmaceutical Sciences

6月 2014 - 6月 2020

認定資格

• Registered Pharmacist

  Telangana State Pharmacy Council (TSPC)

  1月 2020 - 現在