Pharmacovigilance Affiliate Model
Why outsourcing pharmacovigilance makes sense at an affiliate level
In the past, the primary role of a pharmaceutical company’s affiliate office was to liaise with local health authorities. However, with the harmonisation and globalisation of pharmacovigilance regulations, its role has been extended and responsibilities are more stringent.
These factors have resulted in dramatic changes in the role of the local affiliate office, and there is a risk that local pharmacovigilance activities are being overlooked.
An outsourced affiliate model enables pharmaceutical companies to access skilled resources with expertise in local pharmacovigilance activities, providing the scalability, transparency and standardisation required to improve regulatory compliance.
In this whitepaper, we consider the benefits of adopting an outsourced model for pharmacovigilance that is centrally managed and geographically dispersed, ensuring efficient and compliant delivery whilst retaining the effectiveness of a local presence. We also explore the current challenges associated with managing local affiliate pharmacovigilance activities and potential ways to overcome these.