Local Pharmacovigilance Specialist (Arbo)

Full-time Bio-farmacéutico y salud, Gestión y operaciones

Join to apply for the Local Pharmacovigilance Specialist role at PharmaLex.

Responsibilities

• Set up and manage the local pharmacovigilance system
• Local literature search
• Local ICSR management
• PV intelligence screening
• Local PSMF maintenance
• Set up local organized data collection
• Local PVA management
• Local adaptation and submission of PSUR / RMP
• Local signal detection
• Implementation of additional risk minimization measures
• Review materials relating to local post‑authorization safety
• Participate in PV‑relevant audits and inspections
• Attend regular meetings according to the project meeting schedule
• Provide monthly PV report on the status of the local PV system in the country/ies
• Ensure PV training of affiliate employees, service providers and third parties
• Close cooperation with the global PV system of the client as well as relat...