Pharmacovigilance Associate

1 day ago


Bengaluru, Karnataka, India Entirety Hr Solutions Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Job Role: Senior Pharmacovigilance Associate

  • Processing of the Individual Case Safety Reports (ICSR).
  • Literature screening activities.
  • Accountable for reviewing and assessing the validity of literature abstracts and articles with further processing onto the safety database if required.
  • Extended Eudravigilance Medical Product Dictionary (XEVMPD) maintenance and EVWEB updates including Summary of Product Characteristics (SPC/SmPC), Patient Information Leaflet (PIL) inserts and updates.
  • Preparation of Signal Detection Reports and Addendum to Clinical Overview (ACO).
  • Perform the review of SmPC and PIL in comparison to reference products.
  • Monitor the safety updates on safety signals for the client products.
  • Compliance to the standard operating procedures (SOPs) and regulations.


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