Safety And Pharmacoviligance Coordinator
Current1. Monitors and routes information to the appropriate project 2. Records all ICSR documentation and tracks in accordance with Sponsor/customer specification3. Redacts patient identifying information/images in accordance with data protection guidelines ICH GCP and GVP4. Enters data into safety database in accordance specific Sponsor/customer guidelines and Company standards5. Ensures current conventions are followed when entering cases into safety datebases6. Perform file creation, retention, tracking and maintance7. Manage translation process for any source documents requires translation8. Perform, assist with query follow up9. Assist with submission process10. Assist with daily reconciliation process11.Maintains understaning SOPs, WI, GCPs, ICH, GVP