Dr. Hita John

Consultation services, business development and Subject matter expert in Regulatory affairs and Pharmacovigilance. Reporting of ICSRs to suppliers and Health Authorities. Tracking of ICSRs. Prepare and Review Standard Operating Procedures and Safety data exchange agreements. Literature screening. Participate in preparation of Inspection and Audits. Inspected Pharmaceutical Warehouse for Good storage and Good distribution practice

Dossier creation, Classification of Drugs and Registration of products with the Ministry of Health. Prepare and review Standard Operating procedures. Literature screening. Fill CIOMS forms and send them to Principal Companies and relevant authorities.

Triaging, Case processing and Narrative writing for Clinical trials and post marketing drugs. Perform data entry on Argus safety data base, coding of relevant medical Terminology using MedDra, writing descriptive narratives, assisting with reconciliation. Process safety data according to applicable regulations, guidelines, standard operating procedures and project requirements.

Clinical Research & Pharmacovigilance

Orthodontics, Paediatric Dentistry, Prosthodontics, Public Health Dentistry, Endodontics