Leveling Up Your Pharmacovigilance Capability

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Your startup biotech is doing well and you have only needed a single PV expert to oversee the one or two CROs conducting the Phase 1 or 2 clinical trials. You heard that more is needed once you get into Phase 3, and that a really capable and experienced PV leader is now rising to the top of your list.

Before you go looking for this leader it is always helpful to consider what it is that you actually need in this hire. Having a highly experienced PV leader may or may not be the most appropriate hire at this time. Here are a few pointers to ask yourself before you start the process in earnest.

1) Timing - Your Phase 3 study is going well and you anticipate growth not only in the volume of SAE reports coming in, but also having to preparate for FDA and EMA submissions. Too early and there is not enough work. Too late and there is not enough time. Rule of thumb - 12 to 18 months prior to filing is reasonable.

2) Funding - Perhaps the funding for this has not yet been secured, especially the potential for hiring a small team. Expecting a single PV leader to do everything in parallel is not feasible, especially if there are multiple vendors involved or needed for the peri-launch phase when things ramp up operationally in terms of inspection readiness and compliance.

3) Complexity - The more complex the mechanism and potential safety risks, the greater the need for an experienced PV leader. Once locked in, decisions regarding potential risks may have an outsized impact on the future of the product. In this case, building internal expertise even before the Phase 3 protocol is finalized is critical for optimizing the benefit-risk profile. Consulting will be of great help at this stage.

These are just a few suggestions and most likely self-evident, but going through the process of thinking through these and other questions may help you find the best approach.