Pharmacovigilance activities have long been fundamental to companies seeking market approval in both the drug and device development process. For this reason, many companies decide to outsource some of the their tasks in order to improve efficiency in managing their Pharmacovigilance Systems. However, once you know what functions and expertise you want to keep in-house and which PV activities you want to outsource, the next challenge will be to identify potential partners and select the one which will fit your PV needs for years to come.
Below, some tips to follow in selecting your pharmacovigilance partner:
Look for a partner with more than a few years in the business, not only in the Pharma services, but more specifically in safety.
There are many areas to look at based on your core competencies. For example: how many DSURs have been generated by the vendor to date? Is your vendor familiar with GVP (Good Pharmacovigilance Practicies)?
GEO – LOCATION
You should also be comfortable working with global teams and recognize when medical terminology and writing may be different. Be clear if you need a locally based team.
QUALITY AND PERFORMANCE
Regulatory authorities are expecting a total (100%) compliance in expedited reporting and you should not ask for less.
HOW BIG IS YOUR BUSINESS FOR THE VENDOR
Will you get the attention and customization that you need?
KNOW YOUR TEAM
Know the key experts on your PV team as well as their governance model and escalation path to ensure a trusting relationship.
DUE DILIGENCE IS KEY
If you have not had an experienced and qualified auditor to check that the vendor meets your criteria from functional (PV), financial and security (IT, offices, data) standpoints, there is a lot that you do not know about the vendor.
LOOK AT THE PROPOSAL ITSELF
The written proposal will indicate the level of expertise the vendor has about safety activities, international PV regulations and complexity of the PV world.
Have your potential PV provider perform a gap analysis of your current processes to identify what needs improvement to get a sense of their knowledge in the area.
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