Clinical Research, Pharmacovigilance and Medical Affairs in the UK

The UK is the 3rd largest exporter of pharmaceutical medicines and with world-class R & D facilities, the industry funds more healthcare-related research than every other source combined.  There are opportunities for doctors to join pharmaceutical companies, independent Clinical Research Organisations, (CROs) and regulatory bodies such as the MHRA.

The pharmaceutical industry offers a challenging multi-disciplinary commercial environment that requires high calibre physicians who uphold the highest standards of their profession.  Apart from selected areas of research, pharmaceutical medicine is involved in clinical evaluation programmes that support licensing and marketing requirements.  The pharmaceutical physician works across a number of stages of product development and marketing and specifically in 3 key functions:

• Clinical Research
• Pharmacovigilance (Drug Safety)
• Medical Affairs

Hybrid or crossover roles can exist depending on the size and structure of the company and in a small company a single physician may be responsible for all 3 key functions.  Although less frequently available, there are also opportunities for physicians in Regulatory Affairs, Medical Education and Pharmacoeconomics.

Although patient contact may be infrequent or non-existent, pharmaceutical physicians are required to exercise their professional knowledge, skills and experience with due regard for the medico-legal and clinical implications of their decisions and all doctors in this field must carry appropriate professional indemnity.  Regardless of the functional role, each day in the life of a pharmaceutical physician brings new and varying challenges every day and rarely are two days ever the same.

Moving from the NHS into Pharmaceutical Medicine

Physicians come into the pharmaceutical industry in entry level roles and are promoted to senior, management and finally Medical Director level roles with increasing pharmaceutical and CRO industry experience.  There is no definitive level of experience for promotion and much depends on the requirements laid down by each company for a specific role but as a guide, promotion to a senior role typically takes around 2-3 years, a role such as a Medical Manager or Head of a Business Unit usually requires at least 5 years’ experience and roles at Director level require several years’ experience.  Medical Directors with broad wide-ranging experience and expertise sometimes elect to work on a freelance consultancy basis offering ‘interim’ services to 1 or more companies to help meet short-term or immediate needs.

Moving from the NHS into Pharmaceutical Medicine is best achieved at SHO or SpR level with current experience in training rotations and therapeutic areas relevant to pharma company product portfolios.  Candidates from primary care can transition successfully into pharmaceutical medicine but the Government’s new contract ushered in radical changes to primary care services and increases in GP pay, particularly for dispensing practices, that can not initially be matched by entry level packages in pharmaceutical medicine.

Pharma companies look closely at a candidate’s record of employment over the most recent 2-3 years. Medics with a recent history of short-term locum roles often find it difficult to move into the industry.  Medics at Consultant level can be deemed too specialised by many pharma companies and, like GPs, may find the move financially detrimental.  The caveat here is for Consultants who have strong therapeutic area expertise and who have acted as an investigator in clinical trials.  Some pharma companies and particularly CROs have job opportunities that require a strong clinical background with particular specialism and are prepared to offer a commensurate salary and benefits package.

Pharmaceutical Industry requirements for entry level UK Physicians

• Full GMC registration.
• At least 2 years in approved SHO training posts in the UK after gaining full GMC registration.  Most companies also require applicants to have sufficient hospital experience to undertake Pharmaceutical Medicine Speciality Training (PMST) once in the industry.  You can read more about this on the Training page.
• Many pharma companies and CROs prefer membership of a Royal College such as MRCP.
• For a role in Clinical Research, previous clinical trials experience as an Investigator or Sub-Investigator is usually preferred.

Clinical Research Physicians

Are usually office based but with UK & International travel opportunities.  Located in cross functional teams, the Clinical Research Physician is often the team leader. The work covers Phase 1, or Phases II – III development.

Phase I work is conducted in units sometimes described as Patient Recruitment Centres that are separate from the companies where Phase II-IV trials are carried out. Roles in Phase I involve the care and supervision of volunteers taking part in studies.

Roles in Phases II-III involve designing and writing protocols for clinical trials and Investigator brochures, liaising with Investigators in primary/secondary care, medical monitoring of ongoing clinical trials, providing medical advice to scientific and other internal/external groups, obtaining funding and making presentations to senior management and providing input to final study reports before submission to regulatory bodies for new drug licensing.  Having access to global information on any drug, the clinical research physician is able to advise trial Investigators and advance products through development if clinical trials indicate it is safe to proceed.

Clinical Research Physicians are also employed by CROs but often given the title ‘Medical Adviser’, a title in pharma companies associated with roles outside of Clinical Research. As a Clinical Research Physician (Medical Adviser) with a CRO, the work involves providing medical input and advice to sites, Investigators, CRO personnel, the sponsor pharma company, medical monitoring, attending Investigator meetings, representing the CRO at Bid Defence meetings to win business for the company and acting as consultant  to the sponsor pharma company

Clinical Research Physician roles require participation in study team meetings and liaison with drug safety and regulatory colleagues.  Some days might be spent in hospitals or at GP surgeries or meeting with Investigators to gain their input to protocols you are writing and to discuss clinical trial progress. Attending and presenting information at Investigator meetings where everyone participating in a study gets together, is also a key component.

Some of the tasks you can expect to encounter day-to-day are

Protocols

• Writing and reviewing protocols for UK/regional/global studies
• Input into draft protocols
• With Clinical Research Associates, assessing  feasibility and determining provisional patient numbers
• Sending draft protocols to key investigators in the therapeutic area(s)
• Setting up and running meetings to discuss feasibility etc

Site evaluation

• Identifying, evaluating and selecting qualified investigators and investigator sites
• Reviewing site facilities, site staff involvement, ability to enrol patients
• On completion of site visits, getting study team agreement on participating sites

Reviewing

• Case Report Forms
• Output from study meetings
• Medical queries, e.g. inclusion /exclusion criteria, concomitant medications
• GCP issues
• Significant laboratory /ECG values
• Adverse events
• ICD and updates to the Risk Profile

Becoming familiar and keeping up-to-date with

• Product(s) pharmaceutical/pharmacological properties and pre-clinical data
• Regulatory requirements specific to the product
• Disease area(s)
• Journals/publications
• Leading researchers, Key Opinion Leaders and centres of excellence

Input to

• Clinical Development Plan
• Preparation of ethical review submissions (including patient/volunteer consent/information materials)
• Preparation and submission of regulatory approvals
• Management of study budgets
• Clinical sections/analysis to product(s) Licence Application(s)
• Publication of trial results at conferences and in journals
• Implementation of pre-launch disease awareness programmes and other activities
• Key Opinion Leader/Advisory Board activities

Pharmacovigilance (Drug Safety) Physicians

A prescribing physician is familiar with The Summary of Product Characteristics (SmPC) packaged with medicines.  They contain the current understanding of the drug safety profile together with a well expressed quantification of the potential risks that will be experienced by the described patient population in the given indications for treatment. The information comes from existing pharmacological knowledge, pre-clinical and drug development trials and also from wider experience gained with a larger exposure to patients in the marketplace.  Known in the industry as “Pharmacovigilance” its purpose is to collect, collate and evaluate information about suspected adverse reactions. This can be an aspect of the Clinical Research Physician role but due to its importance and increasingly high profile, most companies will have a separate department to assess and monitor the safety of products on the market and those in development.

The work therefore covers the whole gamut of drug development from pre-clinical through to post marketing surveillance studies.  These positions are office based and require close liaison with clinical research, regulatory, medical information and marketing departments to feedback on-going findings and trends, carry out medical assessments, prepare aggregate Periodic Safety Update Reports (PSUR’s) and carry out Surveillance and Epidemiology studies and Benefit/Risk estimations.

This role is data orientated, assessing and interpreting adverse event information to track trends so that the on-going safety of the company’s products is maintained.  Usually, you have responsibility for products in a specific therapy area but in a small company you could have responsibility for the safety profiles of several compounds. Reports need to be prepared and submitted according to standard operating procedures and the role demands good IT/database skills.

Here are just some of the tasks you can expect to undertake day-to-day

Adverse Events

• Handling spontaneous cases from sales representatives, Health Care Professionals, patients, other company employees, market research, database analysis etc
• Handling Clinical Trial Cases (Serious Adverse Events)
• Medical Review
• Entering into database
• Follow up

Surveillance Activities

• Signal detection
• Signal assessment
• Recommending label changes
• Proposing Pharmacovigilance activities
• Answering regulatory enquiries

Risk Management
(a proactive, systematic and more evidence driven approach to evaluating safety)

• Pre-marketing risk assessment
• Anticipating conditions of use
• Quantifying identified and potential intrinsic/extrinsic risks
• Understanding the epidemiology of disease area(s)
• Benefit/Risk assessment

Input to

• Trial planning
• Safety specification
• Pharmacovigilance plan
• Risk Minimization Plan/Risk Map
• Medical review of individual cases
• Regulatory reports
• Periodic Safety Update Reports
• Reviews of Risk Management activities, Post Marketing Surveillance activities and Medical summaries of safety

Liaison

• Sales and Marketing
• Clinical Research Physicians and Medical Advisers
• Health Care Professionals
• Medical Information and Regulatory Affairs
• Regulatory bodies
• Manufacturing

Medical Affairs Physicians

Often called Medical Advisers, these positions sit most often in the Medical Affairs function, have a strong commercial focus and are involved with late phase III drug development but primarily Phase IV work.  The work involves liaising with Key Opinion Leaders (KOLs) who are key prescribers, developing and signing off promotional materials that accurately portray product capability, competitor analysis, preparing the market for new products, Post Marketing surveillance, providing medical information, managing late phase clinical budgets, drafting protocols and analysing clinical reports.

A Medical Adviser is often responsible for creating and supporting a knowledge base in the organisation in new therapy areas and in collaboration with the training department, ensuring the sales force receives initial and ongoing medical training so they understand and convey the scientific benefits of a Brand appropriately.  A Medical Adviser also acts as an ABPI Guardian, providing medical governance to ensure the highest levels of compliance with the Code of Conduct.

Importantly, the Medical Adviser evolves to become the scientific expert on the molecule.  This means they are ultimately able to recognise and recommend marketing opportunities for new disease indications and evaluate products that might be licensed-in to add to the product portfolio for a given therapeutic area.

Medical Advisers need to be fast learners, able to assimilate large volumes of data.   The role presents many face-to-face challenges and requires doctors who enjoy a fast pace environment with ability to excel in communication/negotiation. Although Medical Advisor roles are office based, time is spent away from the desk travelling to meetings with KOLs and to attend or present at conferences and training sessions.  Internal liaison with colleagues in Clinical Research, Pharmacovigilance and Regulatory Affairs is also important but the real thrust of these jobs is medical input to the marketing strategy for products on the market. Launching a new product is a highlight of many Medical Advisers’ careers.

Again, here are some of the tasks you will come across day-to-day

Becoming the Medical expert for a product or group of products

• Strategic awareness of the Clinical Development Programme
• Involvement in late stage (Phase IIIb and IV) clinical trials
• Maintaining up to date knowledge of product(s), applications, issues
• Maintaining contact with Key Opinion Leaders in the medical field and Non-Government Organisations in assigned therapeutic area(s)
• Playing a key role in advisory boards
• Attending frequent meetings and conferences – often overseas
• Networking with potential Key Opinion Leaders and Health Care Professionals

Working with Sales & Marketing team(s)

• Developing the medical content of promotional material
• Ensuring claims are supported by the clinical data available
• Ensuring compliance with the ABPI Code
• Approving and signing-off promotional material
• Guiding marketing activities and discussing campaigns
• Getting involved with activities prior to product launch
• Life cycle management
• Liaison with Health Economics professionals
• Writing and researching the medical aspects of reports for Regulatory Authorities

Working with the Medical Information Team

• Taking a supervisory role
• Ensuring the sales force are up to date with the most recent publications/key issues
• Ensuring any adverse events are passed to the Pharmacovigilance Dept
• Involvement with Regulatory strategies, issues before launch and life cycle management

Involvement with the Sales Team

• Training sales representatives in broad medical aspects of the company’s products
• Answering queries
• Keeping the sales team up to date with new developments, issues and market opportunities