プロフィール詳細

プロジェクトを作成

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Abhishek Kumar P.に依頼

India

Medical writer with 08+ years of experience in clinical research

プロフィール概要

Detail-oriented and analytical professional with expertise in pharmacovigilance and drug safety monitoring, ensuring compliance with global regulatory standards (FDA, EMA, ICH, WHO). Skilled in adverse event reporting, signal detection, case processing, and risk-benefit analysis to safeguard patient health and support product lifecycle management. Adept at collaborating with cross-functional teams including clinical research, regulatory affairs, and medical writing to deliver accurate safety data and timely submissions.

専門分野

• ☆ Pharmacy
• ☆ Pharmacovigilance/Drug Safety Monitoring

サービス

• Writing

Writing Medical Writing, Technical Writing

職務経験

Pharmacovigilance Assoscite

Lambda Therapeutic Research (India)

11月 2017 - 現在

Pharmacovigilance Associate

Lambda Therapeutic Research (India)

11月 2017 - 11月 2025

学歴

M.Pharm.

Geetanjali University

6月 2015 - 7月 2017

認定資格

• MSSO

  ICH

  7月 2025 - 7月 2025