Pharmacovigilance has been defined as the process of identifying and responding to drug safety issues and has grown considerably as a discipline over the past 10 to 15 years. An educational survey in 1994 revealed that more than 320 people currently worked in company pharmacovigilance functions in the UK alone. Pharmaceutical companies are international, hence the number of staff working in this field within the industry, particularly in other European countries and the USA, is far greater. A major pharmaceutical company such as Astra has over 100 permanent, experienced staff in pharmacovigilance within its research and development organisation in Sweden and the UK and a similar number in local operating companies worldwide. This development has been driven by an increased recognition of the role of pharmacovigilance, the investigation and marketing of a wider range of diverse medicinal products and more stringent and detailed regulatory requirements. The number of individual reports of possible adverse drug reactions (ADRs) can be considerable, for key marketed products often more than 1000 case reports a year are received worldwide from health care professionals and other sources.

The aims of pharmacovigilance within the industry are essentially the same as those of regulatory agencies; that is to protect patients from unnecessary harm by identifying previously unrecognised drug hazards, elucidating pre-disposing factors, refuting false safety signals and quantifying risk in relation to benefit. Although the perspectives of companies and the regulatory agencies may be different they now work more and more closely together and share information. However, central pharmacovigilance units in major pharmaceutical companies in many instances are far better resourced and have much greater ‘in-house’ expertise on the safety of their particular products.

Why is Pharmacovigilance important?

When a medicine is released onto the market there is still a great deal that is unknown about the safety of the product. Once marketed the medicines are used by patients who have many different diseases, who are using several other drugs and who have different traditions and diets which may affect the way in which they react to a medicine. Different brands of medicines may differ in the manner in which they are produced and the ingredients that are used. The adverse drug reactions and poisonings associated with traditional and herbal remedies also need to be monitored in each country. The information we receive on the adverse effects of drugs in other countries may not be relevant or applicable to {Country}’s citizens. In some cases, adverse effects to certain drugs may only occur in {Country}’s citizens. In order to prevent unnecessary suffering by patients and to decrease the financial loss sustained by the patient due to the inappropriate or unsafe use of medicines, it is essential that a monitoring system for the safety of medicines in {Country} is supported by doctors, pharmacists, nurses and other health professionals in the country.  The {Drug Regulatory Authority} and the Department of Health’s Essential Drug Programme are committed to improving drug safety through adverse drug reaction monitoring in {Country}. Through the {Drug Regulatory Authority}’s national pharmacovigilance programme, adverse reactions should be reported on a daily basis

What are the main areas of pharmacovigilance?

Pharmacovigilance is a huge and encompassing discipline, but we can broadly divide pharmacovigilance into four main sub-specialisms:

Operations:

This sector is where many life science professionals interested in drug safety jobs will begin their career. Typical jobs within drug safety operations include case processor, drug safety officer/associate and drug safety manager, and of course team lead and directorships. These professionals will collect and record information during preclinical development and clinical trials, in addition to gathering real world evidence (RWE) of adverse events reported by doctors and patients post-market. Operations are also usually responsible for creating standard operating procedures (SOPs), individual case study reports, literature screening and regulatory expedited reporting.

Surveillance:

Professionals who focus more within surveillance tend to look towards risk management and signal detection jobs. This also involves performing analysis of the data collated by the wider division. Professionals in this area can hold an array of titles, the most common of which are pharmacovigilance scientist and drug safety physician, but like in all teams, there are many degrees of seniority and remit available. These professionals perform analysis on the drug safety information gathered by the wider department and assist with the creation and review of aggregate reports. They also create development safety update reports (DSURs) for drugs in clinical research, and periodic benefit risk evaluation reports (PBRER) for post-market drugs. These reports ultimately help the team to draw conclusions around the safety and efficacy of a drug or candidate molecule.  

Systems:

This division is concerned with the building and on-going development of a fully robust and innovative system, charged with the responsibility for housing and allowing access (in various forms) to vast quantities of safety data. This safety data is usually collated by those working in operationally focused roles, but is accessed by all. The systems division constantly has to improve, and stay in line with, changing regulations and requirements for the business/ health authorities, making this a very challenging and vital aspect of drug safety.

Qualified Person for Pharmacovigilance (QPPV)

QPPVs jobs are mainly concerned with marketed drugs and those about to be authorised, but as QPPVs are considered by many to be subject matter experts, their expertise is utilised across the discipline and wider business. These senior pharmacovigilance roles will only be held by very experienced professionals and their focus is to understand, plan for and advise upon the regulations and requirements that companies must adhere to across the EU. This is a highly strategic appointment and one of great importance.

Regards
Rutherford
Managing Editor
Journal of Pharmacy Practcie and Education