Senior PV Associate
Core
Managing Individual Case Safety Reports (ICSRs) and safety data for pharmaceutical and biotechnology clients.
Role type
Senior Individual Contributor Pharmacovigilance Associate
Builds
Safety databases, regulatory reports, and monthly client deliverables
Domain
Life Sciences / Pharmacovigilance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ICSR processing, SAE/SUSAR management, MedDRA/WHO coding, data reconciliation, quality complaint handling, workflow management
Preferred skills
LCPPV/PRLS role execution, SOP adherence
Technologies
PrimeVigilance platform, MS Office
Responsibilities
Processing ICSRs from all sources, performing ICSR follow-up, managing SAE/SUSARs (unblinding, reconciliation), handling product quality complaints, generating database outputs and reports
Seniority
Senior, hands-on IC