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Should Your Pharmacovigilance Team Be Based In-House?

Date: 14 September 2016

What’s your pharmacovigilance (PV) recruitment strategy? With medical drug usage increasing in both volume and variety, there is a greater need than ever before for qualified, experienced PV professionals. Many pharmaceutical companies turn to outsourcing and contractors to fulfil demand, but what are the downsides to this approach?

The growing need for PV professionals

PV is taking on ever greater importance for pharmaceutical companies. Globally, regulators are becoming stricter about testing, monitoring and inspections. An adverse event can rapidly generate negative publicity across the world, impacting company reputation and share value.

In addition, the nature of medical drug usage is changing. There are more products on the market, with increasing levels of sophistication. This leads to an increased requirement for post-market monitoring. Typical patient profiles are also changing, as our ageing population means a growth of acute and chronic disease, with many individuals taking medication for multiple, complex health conditions.

Meeting the need for PV services

Many pharma companies are turning to Contract Research Organizations (CROs) or contractors to supply PV professionals. It is not uncommon to find PV teams where only one or two senior team members are directly employed, with all other functions carried out by a CRO or contractors.

The perception is that the CRO/contracting model provides cost efficiency and flexibility. It saves companies from having to develop in-house processes and structures. However, is there another side of the story?

Where did CROs come from?

Back in the 1980s, CROs began to perform small tasks of low complexity on behalf of pharmaceutical companies. This typically involved repetitive laboratory work, or low-priority background projects.

Over time, CROs took on work of increasing complexity, filling in the gaps in capacity for companies in pharma, biotech and medical device industries. Today CROs carry out a full spectrum of contracts, including highly sensitive areas such as research and development.

The risks of using a CRO

PV is one of those areas where accountability and commitment are paramount. If there is a problematic FDA audit, for example, you need a dedicated PV team that will put in the effort to investigate and correct errors. All too often, CROs and contractors take an arms-length approach to accountability, simply moving to another company or asking for more money to stay when something goes wrong.

The relationship between a pharmaceutical company and a full-time employee is a close one; the worker is more closely aligned with the long-term interests of the business, taking credit for success and responsibility for shortcomings. It is hard for workers at a CRO to match the motivation of directly-employed professionals who will share in the glory if the company creates a successful product.

To get the most from a CRO, continual relationship management is required including monitoring and setting contractual quality indicators, escalation procedures, contingency measures and so on. This active management can undermine the savings a pharmaceutical sought from the CRO relationship in the first place.

The ideal PV candidate

The most popular route into a career in PV is to start with a degree in medicine (MD). However, an MD is not essential for a career in this area; if you have the right experience then it is possible to get to the top without this qualification, although career development may be slower.

Most PV professionals begin their career in a junior role involving case processing, inputting data about the side-effects of products into a system ready for analysis. Following this, progression tends to take one of two paths: line management or specialist services such as risk detection and epidemiology.

Does the use of CRO harm the PV career ladder?

One of the major hurdles in a PV career is making the step from case processing to a senior technical position. This is because the increase in responsibility is significant, and involves considerable risk for the company involved.

If junior roles are outsourced, candidates in the earlier stages of their careers find it challenging to gain the skills and knowledge they will need to progress. They may even be based at a different site to the managing director of their team, with little opportunity to take on more responsibility – and that’s bad news for succession planning.

Why bringing PV in-house could pay dividends

PV is an area of activity where you really need dedicated, accountable individuals who identify with the long-term success of the company. While CRO and contracting might promise to reduce costs and create more flexibility, it is unclear whether this approach can deliver when it really matters.

Want to find out more about bolstering your in-house PV team? Get in touch with EPM Scientific today to learn more about how we can support your talent needs.



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