プロフィール詳細

プロジェクトを作成

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Dr. Shyam Nikethen G.に依頼

India

Medical writer with expertise in producing Regulatory compliant CSR, protocols and SAE reports and Summaries

プロフィール概要

With immense knowledge on Adverse Drug Reaction(ADR) monitoring and reporting, patient care, counselling, prescription monitoring, drug interaction monitoring, FDA modules, eCTD submissions, ICHE6 & ICH E3 principles and Clinical Study Reports; I can provide my learning useful in clinical research and development of any phase of study reports in compliance with regulatory requirements in a flawless and haste free manner.

専門分野

• ☆ Neuroscience
• ☆ Neuropharmacology
• ☆ Drug Development
• ☆ Drug-Drug Interactions
• ☆ Preclinical Research
• ☆ Preclinical Pharmacology
• ☆ Regulatory Writing
• ☆ Clinical Trial Documentation
• ☆ Clinical Study Reports
• ☆ Medical Writing

サービス

• Writing
• Research
• Consulting
• Data & AI
• Product Development

Writing Clinical Trial Documentation, Medical Writing, Non-Medical Regulatory Writing, Technical Writing, Business & Legal Writing, Copywriting, Creative Writing, Newswriting, Audio Transcription, General Proofreading & Editing, Translation

Research Scientific and Technical Research, Systematic Literature Review, Secondary Data Collection

Consulting Healthcare Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Statistical Analysis

Product Development Formulation

職務経験

Assistant Professor

PPG COLLEGE OF PHARMACY

6月 2023 - 現在

Clinical Research Coordinator (Real World Studies)

Spinos Lifescience and research Pvt Ltd

12月 2022 - 現在

学歴

PharmD (Doctor of Pharmacy)

College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences

9月 2016 - 12月 2022

認定資格

• Registered Pharmacist

  Tamil Nadu state Pharmacy council

  6月 2023 - 現在