- Pharmacovigilance system design, implementation and maintenance.
- Continuous, up to date, pharmacovigilance advice and consultancy.
- Standard Operating Procedures for pharmacovigilance.
Preparations, review, integration and update.
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Documents:
- Periodic Safety Updates Security Reports, Clinical Expert Statement.
- Description of the pharmacovigilance system.
- Risk Management Plans.
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Case Management:
- Management and reporting of suspected adverse reactions.
- MedDRA coding.
- Management and support with EudraVigilance Registration.
- Electronic reporting.
- Compliance Monitoring.
- Literature searches: Periodical and ad hoc.
- Advice on pharmacovigilance databases.
- Post-authorization safety studies (Phase IV), Pharmacoepidemiology and drug use.
- Review of safety agreements for pharmacovigilance.
- Technical (Spanish/English) translations.
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