Services
Pharmacovigilance
DADA's pharmacovigilance department (PVD) is comprised of physicians and life science professionals of varying expertise, providing full pharmacovigilance (PV) services for a wide range of human and veterinary medicinal products. We can support you with safety monitoring throughout the life cycle of your product and implement (local) requirements as and when needed in the EEA.
DADA has a network of qualified local QPPV partners in a significant number of EEA countries, which we will use when you need advice and support in establishing your local QPPV network.
DADA has three specialised teams for Safety Data Management (SDM), Benefit Risk Management (BRM) and Quality Compliance & Training (QCT). Working closely together, from the DADA headquarters in the Netherlands and from the local office in Poland, we provide the following vigilance services for our clients:
- Audits
- Communication with National Competent Authorities
- EU Qualified Person for Pharmacovigilance (QPPV)
- Expedited reporting
- Global and local literature screening and review
- ICSR/SUSAR processing
- Inspection readiness
- Local (QP)PV support and AE/MI/PQC processing
- Organisation set-up and changes
- Periodic safety reporting
- Post-Authorisation Safety Studies (PASS)
- PV SOPs and other controlled operating instructions
- PV System Master File (PSMF)
- Risk Management Plans (RMPs)
- Safety Data Exchange Agreements (SDEAs)
- Signal detection and evaluation – benefit/risk assessment in safety review meetings
- Training in pharmacovigilance
- Veterinary PV support
- XEVMPD population and maintenance
Business hours
- Monday – Friday
- 9am – 5pm
- Saturday
- Closed
- Sunday
- Closed