Senior PV Officer
Core
Managing Individual Case Safety Reports (ICSRs) and safety data for clinical trials in compliance with pharmacovigilance regulations.
Role type
Senior Individual Contributor Pharmacovigilance (PV) Officer
Builds
Safety databases, regulatory reports, and monthly client deliverables
Domain
Healthcare / Clinical Trials / Pharmacovigilance
Required skills
ICSR processing, SAE/SUSAR management, MedDRA and WHO coding, data reconciliation, workflow management, regulatory compliance
Preferred skills
LCPPV (Local Contact Person for Pharmacovigilance) experience, PRLS (Person Responsible for Local Screening) experience, mentoring junior staff
Technologies
PrimeVigilance, MedDRA, WHO
Responsibilities
Processing ICSRs from all sources, performing ICSR follow-up, managing SAE/SUSARs (unblinding, reconciliation, protocol review), handling product quality complaints, generating database outputs and reports, acting as LCPPV and PRLS for designated countries/languages, mentoring junior employees
