Pharmacovigilance

Does your company have the the resources and know-how needed to continuously monitor the safety profile of your company’s products?
 
Don’t worry, we do. The IRW pharmacovigilance team is dedicated, professional  and experienced from both the pharma industry and the CRO world. Our processes are fully compliant with local and international regulations and guidelines, and we work with a fully validated, ICH and FDA 21 CFR Part 11-compliant safety database.
 
We offer a full-service pharmacovigilance solution, acting either as your safety department, or as a reinforcement to your extant pharmacovigilance team. 
 

Services

We offer our services both during clinical development and post-authorisation. They can be provided as a complete solution or as stand-alone services.
 

Pharmacovigilance system	Detail description of the pharmacovigilance system Standard Operating Procedures (SOPs)
Risk management system	Risk Management Plans (RMP) (including safety specification) Risk minimisation plans
Pharmacovigilance training	Basic pharmacovigilance training of non-pharmacovigilance staff Pharmacovigilance training of staff working specifically with pharmacovigilance
Handling of adverse events and adverse drug reactions during clinical development and post-authorisation	Validated safety database MedDRA coding Assessment of seriousness, expectedness and causality Expedited and periodic reporting
Literature search	Weekly literature search
Eudravigilance	Eudravigilance registration Eudravigilance testing Registration of products in Eudravigilance Medicinal Product Dictionary (EVMPD) Expedited reporting to Eudravigilance
Periodic reports	Periodic Safety Update Reports (PSURs). Annual Safety Reports
Signal detection and ongoing safety evaluation	Signal detection and review of new data Signal evaluation Risk/benefit-assessment
Pharmacovigilance audits	Pharmacovigilance audits
Qualified Person for Pharmacovigilance (QPPV) and 24/7 medical support	EU QPPV EU  depute QPPV 24/7 medical support
Outsourcing	Outsourcing of pharmacovigilance consultants