Pharmacovigilance Associate

0 years

2 - 0 Lacs

Posted:15 hours ago| Platform: SimplyHired logo

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Work Mode

On-site

Job Type

Full Time

Job Description

  • Perform case intake, processing, and data entry of adverse event (AE) reports in safety databases.
  • Review source documents such as medical records, literature, or clinical reports for safety information.
  • Code adverse events and drugs using MedDRA and WHO Drug Dictionary.
  • Assess seriousness, expectedness, and causality of reported events.
  • Prepare and submit Individual Case Safety Reports (ICSRs) to regulatory authorities within timelines.
  • Support aggregate reporting (PBRERs, PSURs) and signal detection activities.
  • Ensure compliance with global pharmacovigilance guidelines (ICH, EMA, FDA, CDSCO).
  • Participate in quality checks and reconciliation of safety data.
  • Assist in maintaining safety databases and document management systems.
  • Support team in audits, inspections, and training activities.

Job Types: Full-time, Permanent, Fresher

Pay: ₹261,266.52 - ₹580,569.19 per year

Benefits:

  • Health insurance
  • Paid sick time
  • Provident Fund

Work Location: In person

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