All drugs in varying degrees have side effects. Some unintended reactions are the causes of death. In the domestic production of drugs of the pharmaceutical plants security control is provided by a special department of clinical research. In the representative offices of foreign pharmaceutical companies, this function is performed by a specialist in drug safety.
In the age of globalization pharmacological science of detection, assessment and prevention of ADRs gets special importance. Pharmaceutical supervision service is evaluating the effectiveness of drug treatment and the risks of side effects from their use, identifying the NRL at all stages (from pre to use by patients). Specialist on drug safety becomes a figure number 1 in the prevention of dangerous effects of drugs on humans. The name of specialty may sound differently in foreign pharmaceutical companies: pharmacovigilance manager (from the Latin. Vigilare – awake, to be on the alert), affiliate safety representative, and the manager of pharmaceutical safety, pharmaceutical supervision manager. But they have the same function.
Drug Safety specialist is organizing the collection, processing and transmission of information on the safety of medicines in accordance with international requirements.
This is a relatively new profession. Therefore, it is rare and is in its infancy. On the pharmaceutical market there is not many experienced specialists. But the importance of this problem on a global scale contributes to its rapid development. Global drug safety depends on the proper organization of national pharmaceutical supervision systems, continuous monitoring of the development and quality of medicines, correct and diligent work of experts on drug safety.
Most adverse drug reactions (60%) can be prevented if to eliminate their causes, such as:
• wrong diagnosis, told to patient;
• improper appointment of the drug or its dosage;
• undiagnosed timely allergic or genetic condition that could causes a patient’s reaction;
• self-medication, prescription or without them;
• failure to comply with doctor’s instructions on taking medications;
• interactions with other drugs and traditional medicines, as well as certain foods;
• use of substandard or counterfeit medicines.
Features profession of specialist on drug safety
The main task of the expert in drug safety is the study of the adverse effects on humans. The functions of the expert include:
• the collection, processing and transmission of information on ADRs during clinical studies, reports of doctors, patients and pharmacists in the head office of the production of pharmaceutical agents as well as the Federal Monitoring Centre for Drug Safety Code;
• analysis of consumers’ complaints of drugs;
• making information about ADRs in a special electronic system, database maintenance, accounting and reporting of ADRs;
• dissemination of information on ADRs among employees of the central and local units;
• continuing education and training within the pharmaceutical supervision assessment;
• training for groups of young professionals and related organizations in accordance with the changing requirements of global procedures;
• support existing SOPs (standard operating procedures), as well as their development and update according to changes in global requirements;
• preparation and submission of periodic reports on pharmaceutical supervision: in PSUR – regularly updated reports on safety; in CIOMS – Council for International Organizations of Medical Sciences; in CCDS – description of the drug prepared by the manufacturer;
• archiving documentation about the safety of medicines and the NRL.
Pros and cons of the profession
the high level of wages;
demand for the profession;
participation in the annual European Congress of experts around the world for pharmacological agents;
the possibility of a continuous exchange of experience with colleagues;
possession of useful information on the NRL and the possibility of its use in the family.
inevitable dissatisfaction and negative emotions of people affected by the NRL;
a high level of responsibility.
Place of work
Head offices and representatives of pharmaceutical companies.