Considerations for Good Pharmacovigilance Outsourcing Practices

Abstract

Over the last approximately 20 years, the pharmaceutical industry has increasingly outsourced its research and development activities, including pharmacovigilance, with mixed results. To avoid significant failures, both clients and service providers should understand and openly discuss each other’s needs, avoiding the unrealistic expectations often elicited prior to signing a contract. Clients should ensure the outsourced project is adequately resourced in terms of time allocated to it and the skills and expertise of those who will do the actual work and training. They should recognise that quality can be compromised by cheapness and that a service provider’s physical distance and cultural difference are likely to interfere with communication and reciprocal understanding. Clients should always have a person in house who has a good knowledge of pharmacovigilance, so as to understand each activity in detail. This person should be involved in discussions with the service provider, assessing the support and information that the service provider requires, reviewing the vendor’s work, providing continuous feedback and avoiding confrontation by focussing on the needs and challenges the service provider is facing.