
Local Pharmacovigilance Specialist
- Zaragoza
- Permanente
- Tiempo completo
- 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
- 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
- Close cooperation with the global PV system of the client as well as related global and local departments and functions
- Issue, review and maintain pharmacovigilance procedures (i.e. Standard Operating Procedures, Working Practices) related to the local tasks in connection with client procedures
- Address Medical Information requests (MIR) from multiple programs and sources using approved responses
- 1-2 years experience within pharmacovigilance
- Fluency in Spanish and English