Person responsible for pharmacovigilance
Other denominations
Pharmacological watchdog; pharmacovigilance.
Description
Drugs that reach the market previously pass through exhaustive efficacy and safety studies (pre-clinical and clinical trials). However, there are adverse reactions to drugs which, because of their low incidence in the general population or because they occur in special population groups (children, elderly, pregnant women, etc.), were not detected during the pre-marketing study period. This is why pharmacovigilance, defined by the WHO as "the science and activity related to the detection, evaluation, understanding and prevention of adverse drug effects or any other drug-related problem". is required. The information regarding the side effects of a drug can come from patients, physicians or pharmacists, and is collected on yellow cards. A negative report may result in modification of the summary of product characteristics and use may be restricted or completely forbidden. Pharmacovigilance is mandatory, as it avoids costly errors that could put public health, and the reputation of the company manufacturing or marketing pharmaceuticals, at risk. The person in charge of pharmacovigilance is responsible for the follow-up of the adverse effects of drugs, determine their frequency, seriousness, and incidence, and predict their appearance during the life cycle of the product, from investigation to marketing. They are also responsible for communication with competent authorities.
Tasks
- Collect and analyze ADR (adverse drug reaction) reports.
- Compile alerts on marketed drugs, risks and profits.
- Manage ADR databases for detailled analysis (epidemiology).
- Draft reports on the analysis results for competent authorities and the company.
- Consider the risks and profits of drugs.
- Propose feed-back activities and control the impact. Inform physicians, regulatory agencies and the company about side effects.
- Coordinate and organize regular meetings with toxicologists, epidemiologists, physicians, etc., of the producing company.
- Fill in the yellow cards required by the health authorities.
- Respond to any request for information from the competent authorities in regard to drug safety.
- Create, update, and comply with the established procedures for Good Clinical Practice for pharmacovigilance in force in Spain.
- Ensure regulatory and legal compliance in pharmacovigilance in connection with marketed and research drugs.
| Catalan | Beginner
| Catalan | Advanced
Open
| English | Beginner
