We're looking for Drug Safety Associates!

Responsibilities 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 serious 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 responsible 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 (*Note: Scoutit is an independent candidate sourcing partner for this hiring. All applications, candidate screening, and hiring-related actions are conducted directly by the respective employer’s authorized recruitment team. Relevant candidates will be contacted via email and asked to fill in additional details as part of the next stage of the application process.) Skills: health,databases,gvp

📌 Drug Safety Associate (Bengaluru)
🏢 Scoutit
📍 Bengaluru