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Drug Safety Associate

Drug Safety Associate

2 - 4 years

|

2 Lacs

hyderabad sanathnagar

Posted:4 days ago| Platform:

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Skills Required

drug safety case safety reports meddra psur clinical trials pharmacovigilance

Work Mode

Work from Office

Job Type

Full Time

Job Description

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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Pharmaceuticals

Hyderabad

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