Pharmacovigilance Analyst

0 - 2 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

  • Receive, triage, and process individual case safety reports (ICSRs).
  • Enter event data into PV databases accurately and in compliance with timelines.
  • Code medical terms using MedDRA / WHO-DD.
  • Assess seriousness, causality, and expectedness of cases.
  • Conduct literature surveillance to identify potential safety signals.
  • Assist in preparing case narratives, reports, and documentation.
  • Support creation of aggregate safety reports (e.g., PSURs, RMPs).
  • Ensure adherence to SOPs and regulatory standards.
  • Bachelors or Masters in Pharmacy, Life Sciences, Biotechnology, or related field.
  • Excellent attention to detail and analytical capabilities.
  • Basic understanding of medical terminology and drug safety processes.

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