Pharmacovigilance
ICSR/SUSAR processing
DADA is capable of receiving and processing safety data on your behalf from the public, from health professionals, competent authorities, clinical trials and literature sources, amongst others. The experienced team at DADA will conduct triage of case reports to determine seriousness, enter the data into our pharmacovigilance database, code the medical information according to standardised MedDRA terminology and provide medical review and ongoing surveillance of case reports.
Services
Other services in Pharmacovigilance
- Audits
- Communication with National Competent Authorities
- EU Qualified Person for Pharmacovigilance (QPPV)
- Expedited reporting
- Global and local literature screening and review
- 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