Drug Safety Associate
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Pharmacovigilance professional with 2.5 years of experience in ICSR case processing, triage, and regulatory compliance under global safety databases. Experienced in handling end-to-end case lifecycle, ensuring data accuracy, and maintaining compliance with industry standards.
Performed end-to-end ICSR case processing (initial, follow-up, nullification)
Conducted triage and case prioritization as per regulatory timelines
Ensured accurate coding using MedDRA and WHO-DD
Worked on safety database (Argus)
Performed quality checks and data verification before submission
Maintained compliance with FDA, EMA, and global PV guidelines
Handled serious and non-serious adverse event cases
Bachelor of Pharmacy (B.Pharm)
