Pharmacovigilance
Global and local literature screening and review
The MAH is required to regularly screen the published medical and scientific literature, to ensure that any mention of safety information related to their products is duly noted and reported as needed to Competent Authorities. DADA pharmacovigilance staff is experienced in carrying out these activities on your behalf and can comprehensively manage your literature screening requirements in conjunction with writing periodic safety reports and signal evaluation documents for your products. Our weekly search is not only limited to identification of individual case safety reports, but also includes detection of potential safety issues. Per your requirements, we can also conduct local literature screening in selected territories. DADA performs in house local literature screening for the Netherlands and Poland. Other territories will be outsourced to our vendors. In addition, we carry out ad hoc literature searches for purposes of signal evaluation or for identifying (late breaking) safety concerns for inclusion in periodic safety reports.
Services
Other services in Pharmacovigilance
- Audits
- Communication with National Competent Authorities
- EU Qualified Person for Pharmacovigilance (QPPV)
- Expedited reporting
- 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