Top 3 Leadership Capabilities For Senior Pharmacovigilance Leaders

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For those pharmacovigilance (PV) professionals that have already mastered the basics and are performing well in their areas of expertise (case processing, signal detection, audits and inspections, risk management, etc.…), and are now looking to lead the department, here are 5 leadership capabilities. Knowing the regulations, establishing a global safety database, and ensuring compliance are a given.

1) Know How Everything Fits – No-one can know everything in every function within any PV organization, but it is important to know why the functions exist, what their key objectives are and how they interface with each other. The last one is critically important, since the operational success of the PV system depends not only on each person knowing their role, but also on their ability to handoff or communicate with key stakeholders. This is particularly true for those teams that exist outside of PV, such as the commercial teams designing patient support programs and market research. Do your best to make connections throughout the company at levels – there are no benefits to staying inside your PV enclave.

2) Support Your Staff – Whether you have a large team or just a few team members, there is tremendous value in setting aside time for regular meetings with individuals for both formal and informal updates. If you value a culture based on open communication and trust, you need to model that behavior with every member of your team. For a large team, you will meet most frequently with your direct reports, but do not forget about the others in your team. Something I have found to be effective in coaching and mentoring staff is to attend a couple of group or cross-functional meetings they lead. This gave me the opportunity to observe and provide feedback as well as show them how it is done. Some PV professionals, especially early on in their career, tend to be slow to speak up in front of their clinical development or other functional colleagues in a meeting. It is critical to gain credibility early among peers by showing that you are able to consider all data in terms of medical and scientific accuracy. Your job is not just to recite regulations, but to add value to the discussion based on but not limited to the PV arena.

3) Oversee Vendors – Despite having separate teams responsible for overseeing PV vendor contracting, there is no substitute for subject matter expertise when it comes to ensuring the work gets done. Even with team members managing the PV vendor, it is essential that the senior leader also establish a separate line of communication, escalation and oversight mechanism with the leadership of the vendor. Things can and will go wrong and it is ultimately your responsibility to find a solution or a different vendor in the worst-case scenario. Also, choose your KPIs carefully and never settle for just the standard ones proposed by the vendor – really dig into the vendor workflow and identify additional key leading indicators to monitor. Be suspicious of everything showing green on any dashboard!

These have played a major part in shaping me as a senior PV leader. I still have a lot to learn, so let me know what are other key leadership capabilities that have been instrumental in your success as a PV leader?