Pharmacovigilance Associate
Core
Monitor and ensure the safety of pharmaceutical products by collecting, analyzing, and reporting adverse event information.
Role type
Pharmacovigilance Associate (Case Processing)
Builds
Safety databases, case narratives, and regulatory reports for pharmaceutical clients
Domain
Healthcare / Pharmacovigilance
Deliverable
client delivery
Required skills
Adverse event case processing, MedDRA/WHO-DD coding, case triage, narrative writing, QC checks, aggregate reporting (PSUR/DSUR), regulatory compliance knowledge
Preferred skills
Mentoring new joiners, SOP review, SDEA/KPI/SLA management
Technologies
Safety databases, MedDRA, WHO-DD
Responsibilities
Collect, assess, and process adverse event reports; Partner with cross-functional teams to address safety questions; Manage safety inbox and acknowledge case receipt; Enter case details and write narratives; Code events, drugs, and medical history; Apply product labeling and perform QC checks; Finalize case processing and generate queries
Seniority
Mid-level, hands-on IC