David Balderson, Vice President of Global Safety Operations

Challenges in Achieving Excellence in Drug Safety

David Balderson

[This is the first in a two part series that discusses the challenges faced while driving excellence in drug safety. The series gives consideration to an alternative model that drives patient safety by successfully incorporating people, quality and compliance excellence. This post focuses on People Excellence.]

We often talk about achieving operational excellence in pharmacovigilance (PV) by employing the right mix of people, process and technology. While these are certainly essential enablers to operational excellence, true operational excellence can be achieved if we take a step back and remember that our role in PV is to ensure patient safety and optimize a drug’s benefit:risk profile. With this in mind let’s consider an alternative model that drives patient (and drug) safety by successfully incorporating people, quality and compliance excellence.


Patient Safety










People Excellence

Although, organizational excellence looks very different depending on the size, reach and portfolio of a company, most organizations go through a similar evolution. Smaller companies with a pipeline of products in development have limited in-house PV capabilities and safety is often outsourced along with the clinical development program. Oftentimes there is no single PV database and data is fragmented across CROs so oversight of data is a challenge. As companies reach late Phase III they need to start thinking about consolidating and aggregating their data. They must decide if they want to host their own PV database, where costs are particularly prohibitive for smaller companies, and whether they want to build PV expertise in-house or should any aspects of PV be outsourced?

As companies enter new markets with approved products new organizational challenges come into play as the footprint expands. For example, entry in the European market requires a QPPV strategy to be defined and depending on the company structure, this function may be outsourced. Maintaining oversight of a complex and often fragmented system can be highly challenging, but even more so when the QPPV is external to the organization. Companies need to ensure that open communication and real-time awareness is maintained and allow the QPPV to influence processes across the broader organization, which requires commitment from the MAH and not view the role as an EU-only requirement. As the organization expands, the creation of dedicated QPPV office with additional resource to support the QPPV and manage the various deliverables is commonplace.

As the organization evolves, there is a need to acquire both expertise (e.g. in safety evaluation, RMP development and PSMF management) and enabling tools (e.g. signal detection and tracking). Furthermore, complexity of SOPs and processes needs to be addressed. Smaller organizations can often over-build processes and a more limited PV department. However, these complex processes do not scale well in a larger, more complex organization that needs to keep things simple to help ensure compliance. For companies who decide to build these capabilities in-house, if they continue to grow there will inevitably be points at which they will look at sourcing the work due to the realities of scale and financial constraints. At this stage they need to define what should remain core and what can be outsourced.