Senior PV Officer
Core
Senior Pharmacovigilance Officer managing Individual Case Safety Reports (ICSRs), safety data reconciliation, and acting as Local Contact Person for Pharmacovigilance (LCPPV) and Person Responsible for Local Screening (PRLS) for specific countries/languages.
Role type
Senior IC pharmacovigilance officer (ICSR management & local regulatory liaison)
Builds
ICSR databases, safety reports, and regulatory compliance documentation for pharmaceutical clients
Domain
Life sciences / Pharmacovigilance / Regulatory Affairs
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
ICSR processing, SAE/SUSAR management, MedDRA/WHO coding, data reconciliation, workflow management, mentoring, LCPPV/PRLS role execution
Preferred skills
None explicitly stated
Technologies
PrimeVigilance, MS Office
Responsibilities
Processing ICSRs from all sources, performing ICSR follow-up, managing SAE/SUSARs (unblinding, reconciliation, protocol review), handling product quality complaints, interacting with Medical Information and Quality Assurance, generating database outputs and monthly client reports, mentoring junior staff, acting as LCPPV and PRLS for designated regions
Seniority
Senior, hands-on IC with mentorship duties
