Vigilance Services
"Next-generation Pharmacovigilance"
Azierta’s team of experts provides strategic and operational support for partial or full outsourcing of Pharmacovigilance (PV) responsibilities.
With more than 10 years providing PV services, our experience ensures optimal compliance with national and international PV regulations. Following our commitment to quality, our PV activities are certified to ISO 9001:2015.
Our flexible PV solutions activities meet needs from early development to post-marketing of medicinal products.
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Postauthorisation
Vigilance
Clinical Trial
Vigilance
Human Medicines
Veterinary Medicines
Medical Devices
Cosmetic Products
- Find out our solutions -
Local-QPPV & deputy
- EU-QPPV and deputy
- UK-QPPV and deputy
- Local-QPPV and deputy
PV Quality System Management
- Pharmacovigilance System Master File (PSMF)
- Standard Operating Procedures (SOP)
- Pharmacovigilance Agreements (PVA) and Safety Data Exchange Agreements (SDEAs)
- PV Compliance: Metric and KPIs
- PV Audits Supporting during Health Agency inspections
Aggregate Safety Report
- PSUR/PBRER
- RMP
- DSUR
- ACO
Signal Detection Management
- Signal detection reports
PV Audits
- Internal audits of Pharmacovigilance Systems
- Support and assistance in inspections issued by the Health Authorities
- External audits of subsidiaries, partners and CROs
- In-person/remote audits
Literature monitoring
- Medical Literature Monitoring (MLM) service
- Global Literature Monitoring in global databases (PubMed, EMBASE)
- Local Literature Monitoring in non-indexed scientific journals
ICSRs on marketed products
- SAE/SUSAR during clinical trials
- ICSR on market products
- Vigilazierta, our global and validates safety database
Eudravigilance Registration & Support
- Registration of “New organisation” as non-sponsor
- Registration of responsible person (RP) of pharmacovigilance
PV training
- In house and online training
- Annual and onboarding personnel training
- Azierta Academy – Online training platform with tailor-made training courses
Multidisciplinary scientific knowledge
Digital innovation
Go-to-market models
Global approach
with local support
Support throughout the value chain
Global
offering
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