Global Pharmacovigilance and Drug Safety

Global Pharmacovigilance / Drug Safety

EU&UK QPPV/Deputy QPPV
The roles of the EU QPPV and UK QPPV are required in the respective regulations from EMA and MHRA. Our experienced personnel can perform these roles for both human and veterinary medicines, including medically qualified backup personnel (physician, veterinarian) available as legally required. 

We also provide the role of a Deputy EU QPPV and Deputy UK QPPV for both human and veterinary medicines.

We also provide QPPV EudraVigilance registration support.

Safety Physician, Advice
We can provide assistance with all safety physician tasks and roles all the way from medical review of regulatory documentation to global strategic safety and pharmacovigilance advisory roles, during the entire life cycle of your product. 

Signal Management
We can set up signal detection activities as required and relevant for your products. 
We support management of emerging safety issues, safety communication and recalls.

Our personnel has firsthand experience from PRAC, NOMA, MPA, EMA and WHO

We have experience from working with the EMA EVDAS (Eudravigilance Data Analysis System), DWH (Data Warehouse, Eudravigilance Veterinary Data Analysis System) and IRIS (for signal management and annual risk-benefit statements for veterinary medicinal products).

Aggregated Reports
Authoring, review and submission of periodic safety reports in different formats applicable for different markets globally, such as PSUR, PBRER, PADER, ACO, SUSAR LL’s, DSUR.

Adverse Event/Reaction Management (Human and Veterinary)
We assist with collection, validation, triage, follow-up, data management including data entry into Eudravigilance (Human/VET), MedDRA/VeDDRA coding, quality management, evaluation, submission to partners/EV/MHRA portal, reconciliation and archiving. 

PV in geographical expansion /Market Acquisitions/DD (due diligence)
We support and lead PV teams in Due Diligence/Market Acquisitions/Geographical expansion projects going into new markets or regions globally.

Improvement projects
We have experience of driving different PV improvement and transformation projects both globally and locally, to increase efficiency and quality while still having a pragmatic and lean approach. 

Business Continuity Plans (BCP)
We can assist with creating and maintaining a Business Continuity Plan as well as creating and performing BCP tests and Set-up of BCP risk assessment scheme.

Agreements
We can create, support, maintain Pharmacovigilance Agreements (PVA), Safety Data Exchange Agreements (SDEA), Master Service Agreements (MSA), etc.

We also help you with vendor assessment, negotiation, vendor selection, set-up and maintenance of contracts, vendor management.