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Pharmacovigilance careers opportunities

Published on 28/10/03 at 05:14pm

The relationship between regulatory authorities and pharmaceutical companies may at first glance appear to be pulling in different directions, but that belies their inter-dependence. Without the need for new medicines, authorities would not exist and without regulatory authorities, pharmaceutical companies may have even more stringent barriers placed on their activities.

Pharmacovigilance, monitoring of the safety of medicines, requires an assessment on the origin and reliability of a variety of information about a drug. This can be produced by the Yellow Card reporting system, from specifically designed studies or from the Periodic Safety Update Reports. Assessment is then followed by the research for supporting evidence, hypothesis generation and the seeking of advice from advisory committees. The tends to be an intensive process for at least the first two years after marketing approval is granted.

Roles for clinical and scientific staff

The main work of physicians within regulatory authorities is the assessment of data supporting applications for Marketing Authorisation Holders or of issues raised as a result of safety signals. In broad terms, assessment of an application or a safety issue consists of weighing the benefits and risks of a medicinal product in the context of use for the individual patient and the protection of public health. This is a challenging undertaking and requires mastery of medical and scientific facts as presented by the applicant, searching for supportive information, summarising the findings and forming a judgment on efficacy and safety.

There can also be letters from members of the general public and healthcare professionals to respond to concerning the regulation of medicines. This must be done in an informed and helpful manner, giving professional advice, but avoiding commenting directly on individual patient care.

Career opportunities

Medical assessors, the most common role for physicians, are mainly concerned with the assessment of scientific data supporting applications new drug and abridged applications, clinical trial start-up, variations, renewals, reclassifications and pharmaco-vigilance. Assessors can take on special projects relating to individual drugs or a class of drugs. This is often needed in pharmacovigilance where reviews of the safety aspects of a drug class may be triggered by a public health issue from one product in the class. Reviews can also be much broader, such as drugs and driving or the use of medicines in children. These reviews can be challenging, but are rewarding to carry out and always involve presentations to and advice from experts on advisory committees. There is always a European perspective to be brought to these issues and there may be opportunity for academic publications. Assessors may also be invited to work on a CPMP working party to produce a guideline, for example on drug development in a particular class.

After their appointment medical assessors are expected to develop their regulatory knowledge and competencies across a number of therapeutic areas but they frequently come with experience in a particular medical specialty and their expertise is fully utilised. Perhaps one of the most prestigious roles is to be one of the two representatives to the CPMP.

Requirements for medical assessor positions

Medical assessors join the regulatory authorities from a variety of previous posts, including the pharmaceutical industry, contract research organisations, general practice, the NHS and academia. Most medics will have a higher qualification, eg MRCP, PhD, FRCS, and it would be unusual for an assessor to be recruited in the first two to three years after registration. Practical experience of therapeutics and an appreciation of the risks and benefits of medicines at individual and preferably at public health level are definitely an advantage.

Pharmacokinetics and statistics are competencies that are frequently needed in all forms of assessment and it is worth developing these skills to a high level. In Post-Licensing, pharmacoepidemiology is also a valued skill to have.

Some of the personal qualities required to be a good assessor include:

  • An enquiring and critical mind
  • Ability to assimilate, and assess objectively, large quantities of data
  • Ability to balance the risks and benefits of a medicine and to assess public health issues
  • A desire to work in a European environment
  • Ability to adopt varying leadership and team member styles, from the directive to the consensual
  • A genuine and rigorous concern for patient welfare that is not lost in the day-to-day routine
  • Resilience and a positive liking to work to tight deadlines.

Training, continuing education and revalidation

Medical staff, like all MCA employees, have an annual appraisal which evaluates performance against objectives. The Agency recognises the need for CME and CPD and the importance this will have on career opportunities and in revalidation. There are regular professional forums and seminars with both internal and external speakers, and many physicians attend further education courses, usually in regulatory or therapeutic specialties.

Agency staff are in great demand as speakers at symposia and workshops, and within limits, this is permissible. Many physicians are fellows or members of the Faculty of Pharmaceutical Medicine and there are always three or four assessors each year undertaking a postgraduate course in pharmaceutical medicine in order to sit for the Diploma in Pharmaceutical Medicine. In addition, there is the opportunity for those in pharmacovigilance to study for the Diploma in Pharmacoepidemiology at the London School of Hygiene and Tropical Medicine.

There is a recognised a need for broader professional development and a number of medical staff write papers, referee journals, are lecturers, editors or examiners for the Diploma in Pharmaceutical Medicine and for postgraduate and undergraduate students.

The future

The scientific base on which drug discovery and development is founded has changed and will continue to do so through the continued development of biotechnology, genomics and proteomics. The Agency will continue to seek to appoint high-calibre staff to assess these new kinds of applications. The regulatory environment is also changing. The 2001 review of the new European licensing system will result in significant legislative change that may not be in place for some years but which nevertheless will have a profound effect on the Agency's business and how it operates to protect public health.

The regulatory physician will continue to have a crucial role in this new environment. Assessment of efficacy and safety data will remain at the heart of their work, but availability of, and access, to wider sources of information will impact on the assessment process. The challenge of working in an ever-widening European Community, while meeting national health requirements, will become ever more demanding. The wider government policy to make more medicines available to the public will require assessors to be familiar with the use of meta-analysis and systematic reviews, and have an awareness of government and public health expectations.

These will be exciting times but quite different from the traditional role physicians have been trained for in the past.

N.B. The views expressed are those of the author, and do not seek to represent any official position of the Medicines Control Agency

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