Pharmacovigilance Services

Pharmacovigilance-System

• Implementation & update of the regulatory required Pharmacovigilance System
• Human, veterinary and medical devices
• Pharmacovigilance database and case safety report (ICSR) processing
• Documentation with 24x7 access and QM-based management
• Preparation and update of Pharmacovigilance procedures (SOPs) and templates 
• Integration of Pharmacovigilance in existing QM systems (e.g. GDP, GMP, ISO) and implementation of synergies

Individual Case Safety Reports / Signal Detection

• Processing of Individual case safety reports (ICSR)
• Pharmacovigilance database and electronic reporting
• Follow-up activities (i.e. ICSRs, pregnancies)
• Signal detection, validation and analysis
• EVDAS (Eudravigilance) Monitoring

Literature / MLM /  PSURs / RMP

• Literature screening
• MLM (Medical Literature Monitoring der EMA)
• Legislation Monitoring
• Periodic reports (e.g. PSUR resp. PBRER, DSUR)
• Risk Management Plans (RMP)

Marketing Authorisation and regulatory documents

• PSMF - PV System Masterfile (Module 1.8.1)
• RMP - Risk Management Plan (Module 1.8.2)
• ACO - Addendum to the clinical overview (Module 2)

Risk minimisation measures

• Realisation of additional risk minimisation measures (i.e. educational material)
• Implementation of safety measures (i.e. graduated plan procedure, PSUSA)
• Full support with regards to recalls and Dear Healthcare Professional Communication (DHPC)
• Training on Pharmacovigilance topics, processes and tools 
• Socialvigilance

QPPV, Graduated Plan Officer acc. to German Drug Law

• We also assume responsibility and act on behalf of the client as GPO according to the German Drug Law (Stufenplanbeauftragter) or as Qualified Person for Pharmacovigilance, EU-QPPV.

Audits

• Professional Pharmacovigilance Audits
• Support of internal audits (self inspection)
• Audit management
• Corrective- and preventive actions (CAPA)
• Regulatory inspection readiness 

Pharmacovigilance Agreements

• Preparation and Update of Safety Data Exchange Agreements (SDEAs)
• Professional Review
• Contract Management

Please feel free to contact us. We are looking forward to give you all the strategic and operational support you require.