Pharmacovigilance (PV) Consulting
OZQA provides consulting support within EU Pharmacovigilance (PV) for pharmaceutical and biotech companies operating before and after marketing authorisation. We support organisations with the setup, maintenance, and oversight of EU GVP-compliant PV systems, ensuring regulatory alignment, clear responsibilities, and inspection readiness.
Areas of Support
We provide consulting support within the following Pharmacovigilance areas:
-
Setup and maintenance of EU GVP-compliant PV systems
-
QPPV support and back-up arrangements
-
PSMF creation, maintenance, and review
-
PV SOPs and process documentation
-
PV agreements with partners and service providers
-
PV audits and inspection readiness
-
Ongoing PV advisory support
Support can be delivered as targeted assistance or as broader PV system support depending on the organisation’s size, product portfolio, and regulatory status.
How We Work
Our Pharmacovigilance consulting is:
Aligned with EU GVP requirements
Focused on clear documentation and defined responsibilities
Proportionate to company size and product lifecycle
Designed for real inspection scenarios
We focus on building PV systems that are compliant, manageable, and sustainable over time.
​Typical Use Cases
-
Establishing a PV system prior to first marketing authorisation
-
Strengthening existing PV systems ahead of inspections
-
Updating PSMF and PV SOPs following regulatory changes
-
Supporting QPPV activities and back-up arrangements
-
Preparing for authority or partner PV audits
Our PV consulting is designed to support both emerging biotech companies and established Marketing Authorisation Holders (MAHs) with proportionate, practical solutions.
