Profile Details

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★★★★★

☆☆☆☆☆

USD 10 /hr

★★★★★

☆☆☆☆☆

Hire Dr. Shyam Nikethen G.

India

USD 10 /hr

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

Profile Summary

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.

Subject Matter Expertise

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

Services

• 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

Work Experience

Assistant Professor

PPG COLLEGE OF PHARMACY

June 2023 - Present

Clinical Research Coordinator (Real World Studies)

Spinos Lifescience and research Pvt Ltd

December 2022 - Present

Education

PharmD (Doctor of Pharmacy)

College of Pharmacy, Sri Ramakrishna Institute of Paramedical Sciences

September 2016 - December 2022

Certifications

• Registered Pharmacist

  Tamil Nadu state Pharmacy council

  June 2023 - Present