Adopting a strategic approach to managing PV activities for the mature portfolio

A common issue for biopharma companies is that each local office has its own way of managing processes. Outsourcing these activities to a single service provider enables a more harmonized approach, by leveraging intelligence between different countries, regions, and teams. 

It also helps companies achieve strategic oversight of all pharmacovigilance responsibilities and paves the way for expanding into new markets without the need to bring on additional staff in those regions. 

Another key consideration for companies is the ability to leverage digital innovation tools, such as artificial intelligence, to support key safety activities such as signal management. At the same time, however, investing in digital capabilities is cost-intensive and hard to justify for mature products. Outsourcing management of the mature portfolio, including essential PV activities, to a partner with digital capabilities and expertise gives biopharma companies access to those solutions, as and where it makes business sense. 

As biopharma companies consider their approach to managing PV outsourcing, especially for the mature portfolio, many choose to start small and expand as needed. 

For example, a U.S.-based company may seek a partner to support the QPPV requirements in Europe, leaving that partner to manage PV activities there. Alternatively, if the company has a European office to support central activities (such as the QPPV) but has no local expertise, it might seek a partner to cover local affiliate services rather than having to employ local contact personnel for each market to carry out local literature screening and perform local risk assessments, case intakes, and other local activities. As needs grow and as the portfolio matures, companies may choose to extend the outsourcing engagement to other service lines. 

The emphasis is to seek support where it makes greatest strategic sense, such as where the company lacks resources to manage essential activities or where local expertise is required.  

As products mature and the company’s focus shifts to new product development, the opportunity to expand the outsourcing relationship to achieve global holistic support across PV, regulatory, and quality can be leveraged – how, when and where it makes strategic business sense.