EU QPPV
EAEU QPPV
LPPV

✓ EU/EAEU Qualified Person responsible for Pharmacovigilance
and/or Deputy
✓  Local Contact Person for pharmacovigilance in LT, KG, RU and UA
✓ 24/7 availability

Literature
monitoring

✓ Global literature screening: screen, record and report the findings
✓ Local literature screening: record and report any relevant information
✓ Medical assessment

Auditing

✓ Internal audits and reporting
✓ Audit your pharmacovigilance service providers
✓ Inspection readiness preparations

Pharmacovigilance
System

✓ Development of a suitable system
✓ Setting up processes and writing procedures
✓ Establishment and maintenance of the PSMF

Risk
Management Plan

✓ Development or revision of RMP
✓ Advice on reference safety information updates PIL, SmPC, CCDS
✓ Advice on Risk Minimisation Measures

Periodic
safety update
report

✓ Preparation of PSUR for any therapeutic area
(including submission and follow-up on feedback of authorities)
✓ Advice on reference safety information PIL, SmPC, CCDS
✓ Clinical Expert Overview to support safety variations

Case Processing
and Reporting

✓ Receipt & recording, follow-up & quality control
✓ Medical assessment & Reconciliation
✓ Expedited reporting (entry in EudraVigilance)

Pharmacovigilance
training

✓ Development and performance of an annual awareness training for
all personnel
✓ Customised PV training on specific topics depending on your interests and needs