The evolution of the drug safety market – an overview

Harriet Lawford from the Drug Safety team provides us with the latest instalment of #TeamSEC’s vertical market breakdown. Harriet is in her second spell at SEC having worked here since May 2013, then re-joining the organisation following a relocation to South Africa in February 2016. With a wealth of experience in drug safety within the EU marketplace, she shares some of the latest developments she’s seen in the last four years.

Talk us through what you do at SEC?

I focus on the search and placement of drug safety professionals (pharmacovigilance) across the UK and Europe. It’s rewarding work and involves me working across a number of different verticals and with people from associate level all the way up to vice president (VP). So we’re talking about Drug Safety Assistants and Pharmacovigilance coordinators, Senior Drug Safety Officers, Scientists, Drug Safety Physicians who can be either compliance or risk management focused.

The types of roles I specialise in can have responsibility for line management, are integral to the strategic planning process of safety departments, as well as the implementation of new systems and processes. Usually these people hold a medical degree. Some of the more entry level roles are focused on case processing – i.e. reviewing and analysing all of the documentation and data surrounding drug development – with the more senior roles looking at the reporting required to send to the relevant regulatory authorities.

Compliance is a common theme in the work of the candidates I place, as well as auditing. PV Auditors are very niche & QPPVs are also – they are the only individual who could face criminal charges based on any significant issues.

The niche candidates I spend a lot of time talking to are often risk management physicians and these candidates are specifically important in the department and look at the overall signal detection and safety evaluation of a specific drug. They then report on the risks associated with this drug to deem its safety on the market / in development.

Tell us about what the ideal candidates look like to employers you work with.

For my specialist focus medical qualification is a must and solid clinical practice experience is also something my clients demand. If you’re going to really excite my clients then the perfect candidate would have extensive industry experience within a defined therapeutic area as well as having prior experience within risk management. Experience wise you’re looking at five years or more at a global level.

Historically clients are very keen on those with full authoring experience – risk management plans – as well as those who have come from key global pharma backgrounds. It seems that this gives them a keen advantage over those within a CRO as they have experience working on a specific product with a deeper knowledge into the product overall as opposed to a project basis as in a CRO. The flip side to this, however, is those working in a CRO environment tend to have a larger volume of experience as they are working on a number of projects at any one time.

That perfect person for employers is somebody with excellent communication skills as they are often in direct contact with the relevant health authorities and the level of these positions include a highly strategic influence too – you’re talking about people sitting at director level within an organisation so influencing corporate strategy is vital. I tend to work across seniority levels for these types of positions so those incorporating line management too are generally deemed as ‘gold’.

Given the seniority of these roles, clients are very fond of those coming from a loyal background. Whilst movement from companies is incredibly understandable, we look to supply those who have come from a stable background with over four years in the same company.

What sort of personalities do the people you work with have?

Personally I love working within this niche as the element of work these individuals are doing is so interesting. They are highly knowledgeable and display a keen passion for what they do. They’re also very good to talk to from a communication perspective – they have to be, given that they are speaking to regulatory bodies as well as being senior level strategic people within their own business!

I find the people I work with fascinating. Talking to medical doctors who focus on a specific product, in a specific therapeutic area, looking at every different degree at how a drug changes and what it’s doing to every human that interacts with that drug. The impact that these people are having on the changing landscape and lifestyle of all of us through their work is really interesting to find out about.

What’s changed in this space in the last few years?

The challenge within the drug safety market is that it’s always changing. So there is always expectations to deal with the latest regulations and adapt. With a continuous focus on effective and safe drug therapies, both regulatory agencies and the pharmaceutical industry are making efforts to improve the safety of drug development. Over the years we have seen that there is expectation to do more in terms of safety evaluation and risk management planning, compliance and auditing (whilst on a tighter budget to achieve this). I have personally seen that the pressure felt by these large organisations are then being transferred to the CROs and consultancies chosen to outsource these activities.

Another and more recent change we have seen is with the EU QPPVs. With the announcement of Brexit we saw what one can deem as a pharmaceutical panic and many companies were trying to stay ahead of the curb by relocating their EU QPQPVs/ positions to Europe (specific focus on Sweden and Germany). The EMA will likely be moving out however the cabinet ministers have announced that specific plans shall be put in place to make things work. I believe that with the initial announcement of Brexit there was an element of panic but slowly we are seeing everything begin to stabilise once again.

 

We’ll be putting together a separate blog on Brexit and how it affects this market in the coming weeks, so stay tuned for more information and if you’d like to talk to Harriet in the meantime, you can get in touch on +44 (0) 20 7255 6600.