Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines
Monitor and download ICSRs from Eudravigilance (EV) for valid ICSRs
Processing literature, spontaneous as well as clinical trial and solicited cases
Schedule and perform search of literature reports for valid ICSR in PubMed and MLM
Responsible for generation of reports and submission to health authority and business partners
Ensure data entry of responsible and non-serious ICSRs (Spontaneous, Solicited and literature) in ARGUS as per client SOP and WI with high level of data accuracy
Responsible for coding events, indications and patient history based on MEDDRA
Coding of suspect products as well as concomitant., Amending the narrative when required, Performing Labeling of events




Responsible to obtain follow-up information for all serious and non-responsible cases as per the guideline on Positive Pharmacovigilance Practices (EU-GVP).
Perform the submission of the processed cases to regulatory authority and report distribution to Partner.
Communicate and interact effectively within and across all client key stakeholders and within internal team management as appropriate
Attend all the internal trainings and client trainings and ensure compliance with applicable guidelines
Track and perform daily and monthly reconciliation of ICSRs as per client requirements

📌 Junior Drug Safety Associate Bengaluru (India)
🏢 Indegene
📍 India