Silpa Mol John

Providing written, unbiased, constructive feedback on manuscripts, maintaining high ethical standards to support the identification of potential research misconduct, and conducting Literature review

• GDP (Good Documentation Practice) for patient information/Reports • Standard Operating Procedures (SOPs) updating and compliance • Training Pharmacy technicians and trainee pharmacists. • Liaise with doctor and other health professionals to support patient safety

• Processed and quality-checked Individual Case Safety Reports (ICSRs), including AE/SAE data, ensuring compliance with GCP, FDA, EMA, and ICH guidelines. • Supported clinical trial documentation management by performing triage, reconciliation, and quality assessments of study documents in the electronic Trial Master File (eTMF), maintaining inspection-readiness. • Coordinated safety data reviews and discrepancy management across platforms (eCRFs, ARGUS, eTMF-Phlex, Veeva Vault, Medidata, SharePoint)