- 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-serious cases as per the guideline on Good 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)
🏢 Indegene
📍 Bengaluru