Drug safety physicians can gain a broad view of the pharmaceutical industry and how it works through their involvement with the full life cycle of a drug.
They are normally reasonably senior physicians with between five to 10 years of industry experience and their role is normally global and specific to a brand or therapeutic area. Drug safety physicians can gain a broad view of the pharmaceutical industry and how it works through their involvement with the full life-cycle of a drug, from inception through to maturity. They operate on either a local safety level or a global/international level. The work is fairly similar, but we will concentrate on the local level where most people begin.
What do they do?
A drug safety physician working in the UK affiliate of a multinational company would typically find him/herself managing the locally reported adverse events. S/he would act as a conduit between the company’s international safety group and the local regulatory agency. The physician of a large company may work in a big group that includes drug safety scientists and administrative staff. In smaller affiliates, the physician could be the sole member of a safety team and will, therefore, have to be able to organise everything himself.
Can I do it?
Only qualified medics need apply. Drug safety requires sound and general medical knowledge and a solid clinical background. Keeping up-to-date with medical advances and new regulations is an essential part of the job. Good interpersonal skills, the ability to work as part of several teams to tight deadlines and an inquisitive mind are all a must.
Local safety physicians need to have a good relationship with the local clinical research, regulatory affairs and marketing teams. This is because they need to review and act upon the adverse events occurring in locally run clinical trials. Part of the role is the development of risk-benefit programmes showing that the benefits of treatment are reasonable against a product’s side effect profile. Most companies also have some purely locally licensed products, which they expect the local affiliate to manage from all perspectives, including drug safety. This can be a great opportunity for the local safety physician who will be involved in the preparation of regular Periodic Safety Update Reports (PSURs) and who will also work closely with the regulatory affairs team to answer regulatory authority questions and support the renewal of marketing authorisations.
Career development
Safety physicians have a fantastic opportunity to study and develop further expertise in the science and application of drug safety. Consequently, there is considerable scope for moving up the ladder or across into different fields. Possible moves include: clinical research, regulatory affairs and moves into commercial roles. In addition, the close relationship with regulatory agencies and specialist safety organisations offers the potential for a career extending into these environments. For example, senior members of the Medicines and Healthcare Regulatory Agencies (MHRA) have been recruited from industry.
The role is challenging and variable and makes a real difference to public health and to your company’s commercial goals. You need to have an enquiring mind and logical thought processes alongside good interpersonal and communication skills.
Who needs them?
Any pharmaceutical company or company producing medical equipment needs drug safety physicians.
See www.abpi.org.uk for further information.
