Quality & Compliance
Safety & Vigilance
14 june 2023
Pharmacovigilance is the science and activities related to detecting, assessing, understanding, and preventing adverse effects or other drug-related problems. It is a critical component of the pharmaceutical industry, ensuring drug safety and efficacy. Pharmacovigilance is a continuous process that requires a lot of resources and expertise to ensure that adverse events are reported and managed appropriately.
Most pharmaceutical companies outsource their pharmacovigilance activities to service providers to save costs and improve efficiency. These service providers are experts in pharmacovigilance, providing a range of services such as safety data management, medical information, signal detection, risk management, and regulatory compliance. Choosing the right service provider is crucial for the success of your pharmacovigilance program, and it requires careful evaluation of prospective service providers and effective supervision of the relationship with the chosen provider.
MAH seeking to outsource any PV activities should have standard operating procedures describing selecting, contracting and managing service providers.
The selection process should be streamlined and follow below steps:
Once the service provider is finalised and the contract signed, MAH should:
As the outsourcing model is implemented, Oversight activity should come into place.
By carefully evaluating prospective service providers and actively supervising their relationship, MAH can ensure that your pharmacovigilance needs are met effectively and efficiently.
ProductLife Group has internal experts who have conducted third-party audits on clients’ existing partners, providing an objective overview of their current landscape. Whether your company is new to working with partners or has been for many years, PLG provides tailored solutions in partner selection and management processes. Contact us for more information on how we can support your goals around safety and compliance.
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