Kalyan Jha

Profile:

Registered Pharmacist with almost 3.5 years of Experience in Pharmacovigilance ( good hands on experience in ARGUS & ARISg) for overseeing all aspects of adverse event processing and reporting for assigned investigational and marketed product as peer reviewer and as case processor which involves MedDRA and WHODD coding.

Key responsibility:

1.Receives and processes individual case safety reports (ICSR e.g. Serious

adverse events, adverse events of special interest and suspected ADRs) from

clinical trial, spontaneous (Post Marketing Surveillance) and from published

reports (e.g. literature, received from Regulatory Authorities)

2.Tracking of received ICSR.

3.Case data entry and case processing of Serious, Non-Serious, Lack Of Efficacy, Non-Intervention Study, Invalid, Death/Life-threatening Cases. 4.Review of cases.

5.Coding terms as appropriate and causality assessment.

6.Sending the pending query reports to sites.

7.Narrative writing as per SOP.

8.Working knowledge of ICH/GCP guidelines and MedDRA and WHO DRUG dictionaries.

9.Updating narratives when updated information is received, as appropriate

listing with customer/marketing authorization holders, executing case closure,

reconciliation and preparation of events for archiving.

10.Monitoring on the new colleagues on case processing and Quality Review. *Contributing to online/offline Quality Review of entered data.

was promoted as Subject matter expert (SME)and Peer reviewer in 2022.