Vendor Management
Joint PV audit report:
Save time on your pharmacovigilance audit
Meet your obligations as a marketing authorisation holder without a lengthy auditing process by obtaining an independent joint audit report of PharmAdvice’s pharmacovigilance services.
Pharmacovigilance provider audits are mandatory
As a marketing authorisation holder (MAH), you are obligated to audit your pharmacovigilance (PV) vendor on a regular basis. However, a typical deviation noted in inspections by the Danish Medicines Agency is that auditors do not have sufficient experience in pharmacovigilance, and subsidiaries have not been audited.
Conducting a proper PV audit requires expert knowledge of laws, regulations and pharmacovigilance requirements; it takes time away from your core activities; and most small and medium-sized companies don’t have inhouse resources to ensure a compliant audit but must rely on an independent auditor at great expense.
Audit of the Marketing Authorisation Holder's (MAH) pharmacovigilance system should cover governance, risk management, and internal controls, as well as pharmacovigilance activities delegated to another organisation, such as PharmAdvice.
Joint PV audit report available
With PharmAdvice as your pharmacovigilance service provider, you can gain access to a joint audit report provided by an independent third-party pharmacovigilance auditor.
The joint PV audit report enables you to more easily fulfil your obligations as an MAH to ensure that your pharmacovigilance provider follows all relevant regulations, standards and guidelines.
Participation in the joint PV audit saves you most of the time you would otherwise spend on conducting PV vendor audits and ensures that you can document audits of your PV service provider when inspected by regulatory agencies.
Please note that it is your responsibility as a marketing authorization holder to ensure that the joint audit report is adequate for your auditing needs, and that obtaining the report can form part of but does not replace a pharmacovigilance audit strategy or program.
Benefits of the joint audit report
Save time
Obtaining the report saves you most of the time you would otherwise spend on the pharmacovigilance audit of your PV service provider.
Save money
As several customers take part in the joint audit, you get the report at a fraction of the price of an external pharmacovigilance audit.
GPV compliant audit
The audit is conducted by an experienced and trained pharmacovigilance auditor, which is your guarantee that the audit report meets the requirements of the EMA guidelines.
Independent, third-party auditor
Pharmacovigilance auditors must be objective. To ensure this, the joint audits of PharmAdvice’s services are conducted by an independent, unbiased GVP auditor.
We select an independent professional auditor with extensive practical and theoretical pharmacovigilance experience as well as experience in auditing pharmaceutical companies and service providers to EMA standards. To ensure continued objectivity, we change auditors every few years.
How to obtain the audit report
Fill in the form below, and we will contact you to verify your request and answer any questions you may have.
Any further questions?
If you have any further questions about the joint audit report or pharmacovigilance handling in general, please don’t hesitate to contact me.
Susanne Felumb, CEO, PharmAdvice.
