Quantum Solutions IndiaDrug Safety Specialist- Medical Writer
Dec. 2011 - Apr. 2014India- Clinical Study Reports (CSR) Narrative writer and quality reviewer.
- Development of CSR narrative templates and training team on clinical protocols and eCRF
- Assessment of medical information
- Retrieval of outputs from databases like Oracle, JReview, Spotfire, ARGUS, ARISg and MedDRA.
- Comprehensive experience with ICH and GXP guidelines
- Conducted training and change management processes to improve operations.
- Trained on clinical trial documents including clinical trial protocols, case report forms (CRF/eCRF),
consent forms, and clinical study reports (CSR).