Pharmacovigilance QMS Package
Build the Quality system behind your internal pharmacovigilance activities. The OZQA In house Pharmacovigilance QMS Package provides the procedures, forms and Quality framework needed to establish and operate a structured EU pharmacovigilance system within your organisation. Designed for pharmaceutical companies that want to maintain pharmacovigilance capabilities in house while retaining the flexibility to outsource selected activities to qualified partners.
EU PHARMACOVIGILANCE SYSTEM
Establishing an in house pharmacovigilance system requires more than individual safety procedures. Your organisation needs a connected framework for responsibilities, safety information, case management, regulatory reporting, signal management, risk management, oversight, training and maintenance of the Pharmacovigilance System Master File. OZQA provides the documentation framework. You choose whether to implement it internally or with support from our pharmacovigilance and Quality experts.
Build a PV system on your own or with our help.
COMPLETE
PV
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BUILD A PV SYSTEM
YOURSELF
Build a PV system yourself with OZQA's 98% pre-written GxP compliant documents. Establish your own complete EU-PV system with an audit-ready documentation package.
Ideal for
Organisations having in-house EU-PV with experienced internal quality resources available to customise and implement the QMS.
Package Includes
Pre-written SOP's
Ready to use log forms
COMPLETE
PV
___
BUILD A PV SYSTEM
WITH SUPPORT
Starting from scratch? Let's help you build a complete PV system with our pre-written GxP compliant documentation. OZQA's experts can guide you all the way to audit-readiness.
Ideal for
Organisations that need a complete EU-PV system and support adapting it to their products, organisation and outsourced operations.
Package Includes
Pre-written SOP's
Ready to use log forms
Customisation
Implementation
5 h. training
14 days support
FROM SAFETY INFORMATION TO OVERSIGHT
Establish the processes behind your PV system.
An EU pharmacovigilance system brings together people, procedures, safety information, regulatory reporting and ongoing oversight. The MAH must operate a pharmacovigilance system and have an appropriately qualified EU QPPV permanently and continuously at its disposal. The system must also be described in a Pharmacovigilance System Master File that is maintained and available for inspection. The OZQA package provides the documentation framework needed to establish these activities as connected processes rather than isolated procedures. The documentation package supports the establishment and operation of your pharmacovigilance system in accordance with applicable EU GVP requirements.
FROM SAFETY INFORMATION TO OVERSIGHT
Establish the processes behind your PV system.
A functioning pharmacovigilance system must support the continuous collection, evaluation and management of safety information throughout the marketed product lifecycle. EU legislation requires MAHs to use their PV system to scientifically evaluate safety information, consider risk minimisation and prevention and take appropriate measures when necessary.
Documents included in the complete package
Pharmacovigilance
Your pharmacovigilance system should support:
Pharmacovigilance roles and responsibilities
QPPV governance and back up arrangements
Collection and management of safety information
Individual Case Safety Report management
Regulatory safety reporting
Signal management
Periodic safety reporting
Risk Management
Safety communication
Literature surveillance
Pharmacovigilance agreements
Training and competence
Pharmacovigilance audits
PSMF maintenance
PV Quality metrics and oversight
EMA confirms that the QPPV is responsible for establishment and maintenance of the PV system described in the PSMF, while the MAH remains responsible for the system and its compliance.
ALREADY HAVE A CORE PV SYSTEM?
Add documentation to your existing PV system.
If you already have a pharmacovigilance foundation in place OZQA provides pre-made QMS packages including all SOPs and forms needed to stay compliant. Choose to update your QMS with your own internal personnel or get hands on support from our expert consultants.
ADDITIONS
PV
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UPDATE PV SYSTEM
YOURSELF
Update your current PV system yourself. Add the processes required to evolve your existing system with 98% pre-written GxP compliant documents.
Ideal for
Companies with established core pharmacovigilance processes and internal resources to implement the documents.
Package Includes
Pre-written SOP's
Ready to use log forms
ADDITIONS
PV
___
UPDATE PV SYSTEM
WITH SUPPORT
Already have a foundational PV system but don't have the resources to implement the documents yourself? Let's help you all the way to GxP compliance.
Ideal for
Companies with established PV system but limited resources. We help you all the way!
Package Includes
Pre-written SOP's
Ready to use log forms
Customisation
Implementation
5 h. training
14 days support
Pharmaceuticals
For Marketing Authorisation Holders, the PV system needs clearly defined interfaces with the wider pharmaceutical quality organisation.
Bring together the documentation needed to support product safety, ingredients, manufacturing, claims and regulatory compliance. Ensure regulatory, product and Quality documentation is aligned before commercial distribution begins.
BUILT TO WORK TOGETHER
Not just individual templates.
Our products are developed as parts of connected quality processes. Procedures define how the process works and forms capture the required evidence, and related processes connect one document with the wider quality system.
PAPER TO DIGITAL QMS
Use your existing eQMS or let us help you choose one.
The OZQA PV system is system independent. You are not required to purchase a specific software platform to use our documentation. The system can be implemented within an appropriate existing system or eQMS. If you are moving from a simpler setup into a dedicated electronic QMS, OZQA can also help define your requirements and assess suitable solutions. The system should support your quality processes and regulatory responsibilities – not dictate them.
GXP DEVELOPED STANDARDS
Built by life science QA professionals
OZQA combines practical quality and regulatory experience with ready to implement QMS documentation. Our approach is designed for organisations that need a compliant and scalable quality framework without building unnecessary complexity into their operations. Whether you are developing your first therapeutic candidate or preparing to move towards clinical development, we help you implement the level of quality management that is appropriate for where you are today.
 GMP |  GVP |
|---|---|
 GCP |  GDP |
CHOOSE WHAT YOU NEED
Three ways to build your PV system.
OZQA provides ready-to-use quality documents, complete QMS packages designed specifically for regulated companies, and expert quality support. Whether you're starting from scratch, improving an existing system or preparing for your next milestone, we help you focus on what actually matters.
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FREQUENTLLY ASKED QUESTIONS
FAQ
Building a PV system often raises practical questions. How much documentation do you actually need? Which SOPs should be implemented first? Do you need an electronic QMS?
The right answer depends on your organisation, outsourced activities and regulatory roadmap. A PV system should therefore be proportionate to the activities you perform today, while providing a foundation that can grow with your organisation.