Profile Details

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USD 10 /hr

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Hire Damodara rao K.

India

USD 10 /hr

Regulatory Labeling , medical writer Expert

Profile Summary

• Preparation of Clinical and Non-clinical documents (M2, M4, M5) according to Authority requirements. • Preparation of Artworks using various tools, according to country requirements. • Preparation of PSUR, RMP, PSMF, PBRER documents as per current Pharmacovigilance guideline. • Preparation of Labelling documents according to country requirements.

Subject Matter Expertise

• ★ Regulatory Affairs
• ☆ Pharmacy
• ☆ Drug Development
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Pharmacovigilance/Drug Safety Monitoring

Services

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

Writing Clinical Trial Documentation, Technical Writing

Research Market Research, Meta-Research, Feasibility Study, Fact Checking, Gap Analysis, Systematic Literature Review

Consulting Digital Strategy Consulting, Scientific and Technical Consulting, Regulatory Consulting

Data & AI Predictive Modeling, Data Visualization, Big Data Analytics

Product Development Product Evaluation, Concept Development, Prototyping

Work Experience

Scientist

Aurobindo Pharma

March 2014 - April 2020

Education

M.Pharmacy (Pharmacology)

Sri Vishnu College of Pharmacy

August 2010 - November 2012

Certifications

• Certification details not provided.