Drug Safety Associate

3 days ago


Hyderabad Sanathnagar, India Hetero Full time ₹ 9,00,000 - ₹ 12,00,000 per year

The Drug Safety Associate will process drug safety data, perform case processing, and contribute to safety signal detection and risk management activities.

Roles & Responsibilities:

  • Collect, review, and process Individual Case Safety Reports (ICSRs) from spontaneous reports, literature, and clinical trials.
  • Enter safety data into pharmacovigilance databases (e.g., Argus).
  • Perform MedDRA and WHO-Drug coding of AEs and medications.
  • Conduct literature screening for safety events.
  • Support aggregate safety reports (PSUR, PBRER, DSUR).
  • Assist in signal detection, risk-benefit analysis, and risk management plans.
  • Ensure compliance with global PV regulations (US FDA, EMA, CDSCO, MHRA).
  • Coordinate with clinical operations, regulatory, and medical writing teams for safety updates.

Interview Process: Assessment test, F2F interview.



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