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Indegene
Junior Drug Safety AssociateIndegene • Bengaluru / Bangalore
Junior Drug Safety Associate

Junior Drug Safety Associate

Indegene • Bengaluru / Bangalore
30+ days ago
Job description
  • 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 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


Skills Required
Report Generation
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Junior Drug Safety Associate • Bengaluru / Bangalore

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