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Pharmaceutical medicine

At-a-glance

From the mid-twentieth century, synthetic medicines have increasingly assumed an important role in clinical practice, instigating the need for proper monitoring of their development, regulation and usage. The rising prominence of medicines and pharmaceutical products has paved the way for the development of pharmaceutical medicine as a specialty.

Pharmaceutical medicine is a medical scientific discipline concerned with the medical aspects of research, development, evaluation, registration, safety monitoring and marketing of medicines in the interest of patients. Additionally, roles within pharmaceutical medicine have extended to include the generation of additional data to support the cost-effectiveness and promotional claims of new medicines through clinical study programmes. This data may also be used to handle problems or complaints associated with any medicines released.

Roles for pharmaceutical physicians vary from company to company, though doctors will find themselves working within one of the three main areas which largely correspond to the well-defined phases through which a drug passes in its clinical evaluation:

  • Clinical pharmacology
  • Clinical research
  • Medical affairs or medical services

Through each of these areas, a pharmaceutical physician may work intensively with chemists, toxicologists, statisticians, research associates, government departments, sales and marketing, and ethics committees.

Skills

Good communicator and able to work with many different people
Problem-solver

Rewards

Working at the cutting edge of science
Pharmaceutical companies generally encourage and fund research
Generally, salary is equivalent or in excess of equivalent post in the NHS

Challenges

Limited contact with patients
Need to adjust to corporate life in a commercially driven environment
Ability to operate under pressure

 

Training

Trainees are required to undertake the two years of either core medical training (CMT) or Acute Care Common Stem (ACCS) in acute medicine before progressing to the pharmaceutical medicine specialty training (PMST) programme at ST3 level. The programme will typically last four years, during which trainees study for a diploma in pharmaceutical medicine.

During this period, trainees undertake practical competency-based training that comprises a modular programme in six fields of pharmaceutical medicine (Medicines Regulation, Clinical Pharmacology, Statistics and Data Management, Clinical Development, Healthcare Marketplace, and Drug Safety Surveillance) and one common module in Pharmaceutical medicine which continues from CMT. Trainees must also hold associate (trainee) membership of the Faculty of Pharmaceutical. Medicine of the Royal College of Physicians to be eligible for the the programme.

 

An inside look

Pharmaceutical physician - patient safety and pharmacovigilance

What factors influenced your decision to choose this branch of medicine?
The decreased patient exposure and the fact I would not be employed within NHS, the analytical aspect of the job and the variety and the work-life balance. The experience of strategic level work in a large organisation (compares with requirements of WHO/ UN jobs advertised), no regular on-call and the ability to work from home.

What are the hours like? How intensive is your work schedule?
Usually 7.30am-4pm with occasional flexibility regarding working with teams based in other countries (logging in at 5am/ 6pm respectively according to the time zones). Work is intensive when at work, weekends tend to be free. There are lots of meetings, teamwork, and discussion.

Is there scope for flexibility, for example part-time work?
Yes, as long as I have access to the internet and my mobile phone, I can perform the same things I do at my desk at work. The majority of the teams I work in are based across different sites and continents, and there are usually people dialling in or net meeting.

What are the highlights and advantages of working in this specialty?
The Christmas closedown and there's no on-call. You can get financial bonuses, private medical care, a company car, flexibility with the potential to work completely from home. Also, the majority of the people you work with are very able academically and are qualified to university or postgraduate level. I have complete control of my diary and immediate access to most of the journal papers I need electronically and there's good networking between companies.

…and the challenges and disadvantages?
Having to juggle working on 15 products in 5 teams, needing to be firm with stakeholders and line management about what you are doing and how you are prioritising work. The job is very dependent on the computer working and you can spend up to 10 hours straight staring at a screen. Learning how to work with different line managers and how to negotiate with them: managers in industry are very different from managers in the NHS and you need to work differently with them as they have much more immediate influence on you. Working in an organisation of 60,000 people means that sometimes you have to unravel a mess that has occurred because a team in another country haven't considered or understood the potential global impact of their actions. There's an exam with a 25 percent pass rate if you want to progress in the specialist training and there is a risk you may not be able to retain license to practise with the GMC. Regulatory authorities can ask you for anything they like and set the timeline for your reply.

What are the routine aspects, if any, of your role?
Every day is different. There's no routine timetable, in contrast with hospital, some days can have meetings back to back from 8 till 4, other days nothing in your timetable at all. There is often a high volume of emails to respond to and documents to review in short timescale.

…and the more unusual experiences to date?
Working from home from 4am to 12 noon as my working day for a week to support a team of Americans and Chinese colleagues (plus a Brit or two!) in preparing for a face to face meeting with the Chinese Regulatory Department because there wasn't budget for me to fly out with them and I had other commitments for other products.

Please describe your duties in a typical day.
Arrive at 7.30-7.45am. Read and sort emails. Prioritise tasks. Prepare for meetings. Review draft wording in documents for replies to regulatory authorities, or healthcare professionals. Medically review adverse event reports and draft queries to ask of the reporter for clarity to enable causal assessment of the case. Pharmacovigilance of the adverse events received for my products coupled with external data, e.g. literature, external websites, Baysian analysis of other Adverse Event databases, etc.

What are the necessary personality characteristics for this career?
Clarity of communication- very good written and verbal skills. Happy with a desk job, and good, fast analytical skills. The ability to assimilate a large amount of data quickly, the ability to listen, the ability to negotiate and the ability to change. I started on oncology products and now work on anti-infectives and I've worked on products pre-launch and 15 years post-launch, all with differing requirements.

What advice would you give to someone interested in pursuing a career in this branch of medicine?
Complete enough recognised clinical jobs to satisfy the requirements of entry for Pharmaceutical Medicine Speciality Training at the Royal College of Physicians Faculty of Pharmaceutical Medicine. Take time out from high powered jobs to decide if you really want to leave clinical medicine, although you can get time free to do clinical sessions, however if there is a business need it is difficult to make your clinical work a priority if you want to progress in the industry. Contact the British Association of Pharmaceutical Physicians and see if you can arrange work experience. Do a lot of research, know what the differences are between a big, medium and small pharmaceutical company, a biotec or Contract Research Outsourcing and the different physician roles- clinical study physician, patient safety, marketing medical advisors, clinical trial units. Get clinical trial experience as an investigator, check out the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the Association of the British Pharmaceutical Industry (ABPI) and European Medicines Agency (EMEA) websites for the types of regulations that you need to work within in the industry.

How competitive is this specialty?
Entry: need to choose your entry job carefully, and be aware that you will be competing with experienced physicians and physicians from all areas of the globe. Bigger pharmaceutical companies have opportunities for broad experience and most support post graduate training. If you are willing to travel, you should find a job. Progression depends on what you want, how far you want to go and how much of a commitment you want to make. It is possible to stay at close to entry level for some time.

Additional comments…
If it doesn't suit, I know of people who have successfully returned to clinical practice after time in the industry. If you don't ask at the time the job is offered to you, it's hard to negotiate things like salary and moving expenses after you've started work.


 

Medical Director Oncology for a pharmaceutical company

What factors influenced your decision to choose this branch of medicine?
I was interested in the development of new medicines plus my frustration with the bureaucracy of the NHS.

What are the hours like? How intensive is your work schedule?
The hours vary. Although there are no on calls, it is sometimes necessary to work evenings or weekends, especially when deadlines loom.

Is there scope for flexibility, for example part-time work?
Maybe, but demands are less sessional than in NHS. GPs and hospital doctors often have a structure to their week - clinic on Monday morning, operating list on Tuesday afternoon etc. In the pharmaceutical industry, while there are often regular meetings, often the calendar is dictated by events. For example, certain reports are needed for MHRA or FDA and take over 4 or 5 weeks, short notice travel is needed to resolve an issue at a trial site on the US etc.

What are the highlights and advantages of working in this specialty?
The direct involvement in bringing new medicines onto the market. The chance to show your capabilities and also work with great multi-disciplinary teams. There is also the potential for high earnings.

…and the challenges and disadvantages?
Being a doctor confers no automatic standing anymore. Job security is less than with the NHS, and private sector pensions bear no comparison to NHS ones.

What are the routine aspects, if any, of your role?
Reviewing papers and documents and going to lots of meetings.

…and the more unusual experiences to date?
Meetings with the Food and Drug Administration and venture capitalists. Being quoted in the press.

Please describe your duties in a typical day.
Varies, but usually built around formal or informal meetings to discuss protocols, recruitment or study planning. Sometimes conference calls with external collaborators. Lots of emails.

What are the necessary personality characteristics for this career?
Drive, an interest in new medicines and a willingness to learn.

What advice would you give to someone interested in pursuing a career in this branch of medicine?
Get a qualification in another specialty - MRCP, MRCGP etc. Research roles in industry before deciding. Understand that the culture in companies varies a lot - size of company, nationality, areas of activity, and choose carefully.

How competitive is this specialty?
Fairly competitive because it is a global specialty.

Additional comments…
There is now a training programme within Pharmaceutical Medicine which leads to a CCT and Membership of the Faculty of Pharmaceutical Medicine.

 

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