Clinical Research Physician
Life as a Drug Safety Physician
INPHARM.com
By Dr Madhu Davies
A career in drug safety has the potential to offer a very broad ranging view of the pharmaceutical industry and how it works by involvement with the full life cycle of a drug, from proof of concept through to 'well established' maturity. For many physicians, drug safety is a very carefully researched and positive career choice, as it requires sound general medical knowledge and a solid clinical background. Keeping up to date with general medical advances, as well as the regulatory framework, is part of the job. Good interpersonal and communication skills, the ability to work as part of several teams to tight regulatory deadlines and an inquisitive mind are essential requirements. In my view, the primary function of a safety physician is the protection, maintenance and enhancement of public health. Clearly this is a key role with enormous challenges and responsibilities but also great professional satisfaction.
What you might actually find yourself doing on a day-to-day basis rather depends on for whom you work, how the organisation is structured and whether local or international, big or small pharma.
A drug safety physician working in the UK affiliate of a multinational company will typically find him or herself managing the locally reported adverse events and acting as the thinking conduit between the company’s international safety group and the local Regulatory Agency. The physician in a larger UK affiliate may work in a big group that includes drug safety scientists and administrative staff. In smaller affiliates, the physician is the sole member of the safety team and will need particularly well-honed organisational skills.
Safety physicians in local companies will have a good relationship with the local Clinical Research, Regulatory Affairs and Marketing teams. This is because they will need to review and act upon the adverse events occurring in locally run clinical trials, and the safety role will also include pharmacovigilance, or the safety of marketed drugs.
As a report of an adverse event for a marketed drug comes in, often to Medical Information, the receiver obtains as full a picture as possible of the nature of the adverse event and the circumstances surrounding it, including the name of the drug. It is surprising how often the company receives a call about ‘one of your drugs, but I’m not sure which one’! A preliminary report will be made and reviewed by the physician who will be asked for advice regarding follow-up - time for detective work. This is where good general medical knowledge is invaluable, as you will know which additional questions to ask. Whilst the event is being followed up by the local team, the data are also flowing to the company’s global drug safety team and the relevant regulators.
Most companies also have purely locally licensed products, which they expect the local affiliate to manage from all perspectives, including drug safety. This is a great opportunity for the local safety physician who will be involved in the preparation of regular Periodic Safety Update Reports (PSURs), of which more below, and working closely with the Regulatory Affairs team to answer Regulatory Authority questions and support the renewal of marketing authorisations. Many physicians review monthly listings of the adverse events reported for each product (the building blocks of the PSUR), to look for potential signals. This requires good analytical skills and the ability to think out of the box. Is there a safety signal? If so, what should be done to confirm or refute it? This is a role that requires a lot of thinking, as well as doing, and can impact on the commercial future of the product and even the whole organisation.
So what would a physician working at the company’s global or regional drug safety site do? Whilst some of the work is very similar to that of the local affiliate safety physician, there is a clear view of the even bigger picture gained from reviewing data flowing in from all around the world.
New chemical entities (NCEs) are reviewed by the in-house Research and Development board before being taken into development in man. The safety physician will be part of this board and will work with the pre-clinical scientists to assess the effects of the drug in animal models and the likely relevance and importance to man. Very carefully defined safety assessments will then be incorporated into the clinical development programme. The physician will then typically remain intimately involved with all aspects of the safety of that NCE all the way through to licensing including, for example, liaison with the Regulators and regular review of the Investigator’s Brochure. Significant safety input is required throughout the process, and defining the safety profile accurately from experience to date for the proposed data sheet is very important indeed. At all times, the safety of those who are, or may be, exposed to the drug remains paramount. Following a drug through from pre ‘First into man’ through licensing and onto the market is certainly a very rewarding professional experience.
For marketed products, the physician will review listings of all events reported for their particular drugs regularly for safety signals and take action as needed, including interaction with the senior management board as applicable. Physicians will contribute to the global PSUR, which will be submitted to all countries where a drug is marketed according to local regulatory schedules. The PSUR is an incredibly important document that reflects the current safety status of a product and provides a discussion of any potential for safety concerns, together with the proposed course of action. This document must be complete, robust and scientifically valid.
Discussions with international regulatory groups about labelling in various territories and responses to regulatory authority concerns are a very important safety/commercial aspect of the job. Clearly, whilst it is important to respond effectively to local regulatory concerns, the international company will need to ensure that core safety data for the product issued globally remains exactly that. Marked local variations could fragment global marketing claims, as these must be based on the licence issued for each country - the approved data sheet being part of that licence.
Taking a step back from the everyday activities involved, safety physicians have a fantastic opportunity to study and develop further expertise in the science and application of drug safety.
In terms of career development, there is considerable scope for moving up a ‘safety ladder’, across into clinical research or regulatory and, of course, for more commercial moves. In addition, the close relationship with regulatory agencies and specialist safety organisations offers the potential for a career extending into these environments. Senior members of the Medicines Control Agency have been recruited from industry.
So, if you are looking for a challenging and variable role which makes a real difference to public health and to your company’s commercial goals, you have a keen and enquiring mind, logical thought processes, good interpersonal and communication skills and find detective work interesting, a role in drug safety may well be for you.
[Published: 08 Jan 2003 Source: originally published at http://www.bobgammon.com]