From 22-25 November 2021 Karen Whitelock and I had the huge honour of facilitating the PV stream of the ARCS Workforce and Capacity Summit. The purpose of the Workforce and Capacity Summit was to generate ideas and develop action plans from the various workforce streams to address the skilled workforce shortfall in the sector.
The shortage of a skilled workforce has become critical across the MTP sector, exacerbated by the restrictions on international travel due to the pandemic. The lack of professional standards has contributed to a lack of consistency in the recruitment and development of talent.
However, the pandemic has only exposed a problem which has been there for some time. The MTP Connect Workforce Skill Report has confirmed the skills shortage across the sector. This shortage is creating risks for our sector, in some instances staff are completing activities and functions, for which they don’t have adequate experience, nor the competency to undertake. The skills shortage has also fostered a “buy” rather than “build” approach in some parts of the ecosystem ultimately introducing inefficiencies and adding costs to doing business in Australia.
A survey was conducted prior to the summit and together with some of the brightest and experienced minds in Pharmacovigilance in Australia, we discussed the survey results in detail. We were also privileged to be joined by Phil Tregguno, from the Medicines and Healthcare products Regulatory Agency (MHRA) and International Society of Pharmacovigilance (ISoP), who provided insights and elaborated on initiatives from his experience in the UK.
High among the key areas identified as changing for the PV sector are increased digitisation and offshoring. These two activities have been occurring in a number of companies over the last 5 years, however, the rate of change is increasing. McKinsey & Company report that 40-70% of manual case-processing steps are expected to be automated. The pandemic has had an impact with many companies and regulators worldwide implementing automation to deal with increased adverse event reporting and increasingly complex and unstructured data sources. We discussed how these are impacting the PV workforce now and into the future and what we need to do to transform our current practises in order to meet these changes.
It was interesting listening to the challenges of the bigger pharma companies compared to the smaller ones. With most ‘entry level’ positions for PV being moved overseas (i.e.. call centre/data entry roles) we discussed what training/competencies were required for attracting, engaging, and retaining PV staff. Hiring managers need to consider what are the appropriate experiences and capabilities required for non-case processing PV roles. There appears to be a general shift towards more scientific and data analytical roles in PV. However, for those smaller companies who still process adverse events in-house, the roles of PV interns were also considered.
Global Talent visas were also discussed as a way to bring skilled experts into Australia to support local knowledge gaps. Partnering with academia to address training gaps was identified as an area that we needed to explore more.
Although PV is a highly regulated environment, there seems to be a lack of consistency in the PV career and competency framework within Australia and globally. The World Health Organisation (WHO), ISoP and Institute of Pharmacovigilance have identified this shortfall and have commenced developing these frameworks.
We discussed the usefulness of aligning an Australian PV framework with existing ones to define career progression pathways, benchmark; and understand the knowledge, skills and attributes required for each role. We examined the potential for professional certification, particularly for senior roles like the Qualified Person for Pharmacovigilance. This will help us build confidence that we are selecting the right candidates for the roles and providing relevant onboarding training for success.
The outcomes of the Workforce and Capacity Summit will be consolidated and detailed in a white paper. It will include short-, medium- and long-term actions required to address the shortfalls within PV and other sectors. It was wonderful to be a part of the effective collaboration between numerous pharma industry and other representatives, working together to build Australia as a Centre of Excellence for PV.
By Navinisha Lee (Manager, Drug Safety and PV at Specialised Therapeutics) and Karen Whitelock (Head of PV and Medical Operations at AbbVie)
* This article was first published in Cognition in Summer 2021