Pharmacovigilance 2.0: reskilling for the digital & data science age

Education, training and recruitment strategies need to adapt quickly if the life sciences industry is going to have fit-for-purpose PV teams in future – made up of people who know how to exploit technology to deliver optimum results. Drawing on her extensive experience in pharma operations management, Anna Lukyanova, COO of Arriello, assesses the new skillsets that will be needed. 

It seems inadequate for the life sciences industry’s evolving needs that the people being assigned to pharmacovigilance roles still typically come from pure chemistry or pharmacy backgrounds. It is odd enough today, when essentially much of what they have to do involves administration: ensuring that proper, compliant versions of documents are prepared, with the right signatures. But as advanced technology takes on responsibility for more and more of these repetitive processes, bringing more reliable accuracy - not least tireless attention to detail – as well as unparalleled speed and cost efficiency, even these tasks will be taken away.

At that point, what will be left? What is it that pharmacovigilance professionals will need to do? What value will they add, and where will firms find these people? Training in medicine will be assumed of course, and yes, roles are likely to involve deep scientific analysis, building up more detailed safety profiles of drugs and accurately classifying and reporting side effects, as products are experienced in the real world, and as feedback is captured across international markets.

But other skills will be needed, besides the science itself. Increasingly these will include advanced technology literacy, 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. Because 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 to climb the ladder and assume leadership roles with ultimate responsibility.

Gaps in graduate skillsets

Universities and the wider education need to catch up with this shift in 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 more and more classes and 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.

Senior PV roles prove hardest to fill

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.

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. Workloads will only grow in pharmacovigilance, 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.

Certainly 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.

About the author

Anna Lukyanova

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.

She oversees the company’s pharmacovigilance, regulatory and project management teams, balancing client satisfaction with developing and nurturing Arriello’s growing team.

Anna has worked in the pharmaceutical industry for more than 14 years, in business development and operations. She gained her customer-centric approach from the hospitality sector where she received extensive training and experience after graduating from university in the US.

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