Pharmacovigilance & the tech-driven future: are today’s teams fit for purpose?

As more routine PV work is automated, and as technology literacy moves up the qualifications & experience wish list, a serious review of resourcing and education strategies is needed. That’s if the life sciences industry is going to have fit-for-purpose PV teams in future. Drawing on her many years in pharma operations management, Anna Lukyanova, COO of Arriello, assesses the growing talent gap and suggests how the industry might address it.

It seems remarkable that the people currently assuming pharmacovigilance roles hail largely from pure chemistry or pharmacy backgrounds. As advanced technology takes on responsibility for more and more of current administrative processes, what additional skills may be needed, what value will pharmacovigilance professionals add, and where will firms find these people?

Training in medicine and scientific analysis is a given, but increasingly PV teams will need advanced technology literacy. That’s as intelligent software capabilities help to analyse data in ever smarter and more discrete ways. In an increasingly digital, data-driven discipline, PV specialists will need to understand how to get the most from the advanced tools at their disposal.

Softer skills are going to become increasingly important, too. Since PV is an inter-disciplinary practice, strong communications skills, the ability to lead and take part in group discussions, and to review scope for operations-level efficiency improvements, will all come under the remit of a sound PV practitioner – certainly one with ambitions towards roles with ultimate responsibility.

Are graduates equipped for the work ahead?

The education system needs to adapt to this shift in PV role requirements, as safety matters and patient centricity take central position in authorities’ and the industry’s strategic agenda.

This will happen gradually, but perhaps not quickly enough to match the speed of change in the market. Today, at entry level, pharmacists are leaving education systems with maybe just 10 hours’ tuition on PV requirements and practical application under their belts. Although online courses on PV are emerging, they don’t really go far enough. They can’t adequately cover how to accurately and effectively use signal detection, analysis and reporting tools, or the softer skills needed to manage and maintain oversight of PV operations. The latter might be taught in business school, but not typically in science labs or via e-learning.

This lack of rounded capabilities is causing practical challenges for life sciences companies. If they manage to hire someone with 5-6 years’ experience in PV, this is no guarantee that they will have all the practical skills needed to assume senior-level accountability, move a department forward and deliver fully across its remit. To justify a senior/ line manager role they are likely to need formal coaching in the capabilities they lack, and a chance to absorb a broader range of experience and practical application by working across a range of different scenarios.

Assembling a robust PV team means having the right cross-section of skills – scientific/pharmacy knowledge as a given, but also up-to-date technology skills and awareness of how future/advanced technology is going to transform the PV function in the near- and longer-term future, thanks to its potential to process workloads faster, better, smarter.

To give some context to the growing skills shortage, a study of the opinions of major pharmaceutical companies published by the Association of the British Pharmaceutical Industry (ABPI) in early 2019[1] found that qualified persons, at both a QPPV and QA level, are high-priority appointments for 40 per cent of life sciences companies, and half of respondents cite an inability to find the right skills to be a major issue. The situation is exacerbated in the UK, because of the continued uncertainty over Brexit and the short to medium term impact on the jobs market as border fluidity is reassessed. But the skills shortage is a global issue.

Bridging the talent gap: accessing technology-driven PV services

With the current gap between candidates in the job market and the practical everyday needs of PV departments, it is not surprising that interest in external business process services is rising, because it is within specialist outsourced service providers that the optimum balance of skills exists. Because these personnel have had chance to work across multiple clients’ programmes of work, geared to overcoming differing challenges and priorities, their experience and sense of the market and what’s needed is much more fully formed. They are also likely to have worked with the latest automation technologies, employed to ensure rigour, traceability, accountability and optimised efficiency, and have insight into the next wave of IT-enabled innovations that are coming down the line.

Finally, the other essential quality next-generation PV talent will need is the ability to think outside of the box – about new, improved ways to tackle traditional tasks. Pharmacovigilance workloads will only grow, and sufficiently broadly-skilled team members will only become scarcer as demand outpaces the speed with which relevant talent is entering the job market.

This in turn means that teams will have to come up with ever smarter and more efficient ways to complete work. One thing’s for sure: the days of manually reconciling data, form-filling and cutting and pasting commentary into documents will not be the central facet to PV roles in future. Rather, the remit is likely to become more and more interesting, if also demanding in its scope.

About the author

Anna Lukyanova is COO of Arriello, a provider of innovative, high-impact market access, regulatory Affairs & pharmacovigilance solutions and services for small to mid-sized biotech and speciality pharma firms.  www.arriello.com

Anna.lukyanova@arriello.com

[1] Bridging the skills gap in the biopharmaceutical industry: Maintaining the UK’s leading position in life sciences, ABPI, January 2019: https://www.abpi.org.uk/media/6657/190124-final-abpi-bridging-the-gap-in-the-biopharmaceutical-industry_v3.pdf