Jul 2018
Present
Research Associate
Alembic Pharmaceuticals Limited Vadodara
Vadodara, IN
- Case Processing
- Skillful hand on Eudravigilance & Argus Database
- MLM & NCA Case Processing & Regulatory compliance
- PADER Preparation
- Preparation of eCTD Module 2 including Non-clinical Overview and Summary as well as Clinical Overview and Summary
- Preparation of Environmental Risk Assessment
- Having knowledge of Risk Management Plans
- DCGI Submissions
- Preparation and Maintenance of Pharmacovigilance System Master File