Kunal Rajendra Todkar

1. Case processing in Argus database, Workflow management. 2. PV Mailbox monitoring and record, review and triage of ICSRs. 3. Adverse event coding in MedDRA dictionary 4.Performing follow up queries/clarifications for discrepant data in cases. 5.Performing RCA and CAPA for non-compliance ensuring high quality 6. Performing submission of SUSARs, PSUR, DSUR to Regulatory Authorities, IRB/ECs and investigational sites as needed. 7. SOP, Work instruction, SMP creation, project handling.

1. Involved in safety reports analysis and client communication. 2. Workflow management and worked as Subject matter expert in team. 3. Performed Medical coding using MedDRA, WHODD and CPD. 4. Assisted in the improvement of CAPA process. 5. Coordination and communication with vendors. 6. Worked on Narrative creation, Causality and labeling assessment of events. 7. Having knowledge of PBRER, DSURs, PSURs. 8. knowledge of Solicited, Spontaneous, Clinical trial, E2B, Vendor cases assessment.

1. Case book in and triage in ArisG database. 2. Duplicate case identification and new case creation 3. end to end case processing 4. Training new team members 5. SOP creation and team handling 6. Audit and inspection preparation.

Pharmacuetics

Pharmacy