Local Person for Pharmacovigilance (LPPV)- Poland

Your Job

• Act as primary contact for PV for Competent Authority in the Territory, including 24 / 7 availability if legally required.
• Interface between the EU-QPPV / Global PV team at client and the local regulatory authority
• Set up and manage the local pharmacovigilance system
• Local Literature Search
• Local ICSR Management
• PV Intelligence Screening
• Local PSMF Maintenance
• Setting up local Organized Data Collection
• Local PVA Management
• Local adaptation and submission of PSUR / RMP
• Local signal detection
• Implementation of additional Risk Minimization Measures
• Reviewing materials relating to local post-authorization safety
• Integrated first Level Medical Information and PQC Support
• Participate in PV-relevant audits and inspections
• Attend regular meetings according to project meeting schedule
• Provide monthly PV report on status of local PV system in the country / ies
• Ensure PV training of affiliate employees, service providers and Third Parties

Your Profile