The demand for pharmacovigilance capacity and expertise has been increasing along with more stringent product safety regulations.

This is shifting the landscape of pharmacovigilance outsourcing to more complex activities such as signal detection, benefit-risk management, and risk management planning as well as pharmacoeconomics and pharmacoepidemiology. Consequently, many sponsors are re-evaluating the way they outsource pharmacovigilance and patient safety services.

A wide variety of providers offer contracted safety services, including individual consultants, specialty contract research organisations (CROs), large full-service CROs, and global business process outsourcers (BPOs). Selecting a vendor requires careful exploration and planning to ensure a successful relationship between sponsor and outsourcing partner.

We recommend the following as preliminary steps:

  • Set clear goals and objectives for the engagement/relationship. This entails defining the tasks to be contracted and assessing the expertise available against the level and number of resources required. Factors to consider include:
    • What are the future outsourcing plans? Is this the first in a series of contracts for similar or different services, or is this a one-time request for consultancy?
    • How would other outsourced services be connected to this contract?

There may be times, however, when unplanned resource shortages or an unanticipated workload make the scope of work “a moving target.” Outsourcing can still be a positive experience if the sponsor and vendor communicate openly and address issues immediately. Such situations require extreme flexibility on the part of both parties.

  • Conduct due diligence. Companies should check the provider’s references for insight into actual past performance. Having a record of regulatory compliance and low rates of non-conformity usually indicates the existence of a robust quality management system.
  • Evaluate the business models offered for the requested service. The model selection will be governed by key factors such as complexity and variability versus standardisation, the volume of work involved, and the duration of the project.

ICON offers a range of safety resourcing models to our clients that can be developed into a customised solution to meet your study requirements. Please visit to learn more or contact us to speak with one of our experts.


This blog is an edited version of “Pharmacovigilance outsourcing: Ensuring a positive experience” which appeared in Contract Pharma on 22 Aug 2022. To view the full article, please visit