Avinash Dubey

Hi there! I’m a Drug Safety Associate with hands-on experience in pharmacovigilance operations, including ICSR case processing, triage, MedDRA coding, and narrative writing. I’ve worked with global safety databases like Oracle Argus and Veeva Vault and Clinical SAS medicaand I'm well-versed in international regulatory guidelines (ICH, FDA, EMA, GVP).

With a Master’s in Pharmaceutical Quality Assurance and a strong research background, I’ve also published multiple peer-reviewed articles in areas such as antimicrobial resistance, gene delivery systems, and nanoformulations. Whether it's safety documentation, regulatory writing, or pharmaceutical data analysis — I bring precision, compliance, and scientific clarity to every project.

💡 What I Offer:

• Pharmacovigilance & Drug Safety Support
• Clinical SAS Programming
• ICSR Processing & Case Narrative Writing
• MedDRA Coding & Regulatory Documentation
• Literature Review & Research Writing
• Scientific Article Editing & Proofreading
• QbD/DoE Analysis and Presentation Design