"Don't find fault. Find a remedy."
- Henry Ford, Founder Ford Motor Company -
PHARMACOVIGILANCE
Pharmacovigilance Support is provided under Regulatop's or Marketing Authorization Holder's quality system.
Medicinal products
- Setting-up of Pharmacovigilance Quality System for a Marketing Authorization Holder of a medicinal product
- Providing EU QPPV and Deputy
- Writing Risk Management Plan
- Writing Safety documents like Standard Operating Procedures, Pharmacovigilance System Master File, Periodic Safety Update Report, Safety Data Exchange Agreements, Pharmacovigilance Agreements
- Covering internal Company’s roles e.g. Local Safety Officer and Deputy
- Pharmacovigilance in Italy:
- Local contact of pharmacovigilance
- Local Literature Screening
- Writing/translating Educational Materials and submitting for approval (Risk Minimization Measures)
- Writing Direct Healthcare Professional Communications
- Pharmacovigilance for homeopathic products
Medical Devices
- Performing Vigilance and Surveillance tasks related to Medical Devices (Italy)
Other
- Performing NutriVigilance
- Performing CosmetoVigilance
- Submission of Adverse Events onto databank Vigierbe