Drug Safety

Ensuring the safety of medicines is the task of “drug safety”. It encompasses all measures taken to continuously and systematically monitor and ensure the safety of medicinal products in order to detect, evaluate and understand adverse effects and take appropriate action. In this way, drug safety makes an important contribution to keeping the marketing authorisation of medicinal products up to date.

Components of Drug Safety

Drug safety encompasses all activities that contribute to ensuring the safety of medicines.

Some important components are

• Clinical trials: Clinical trials are used during the development of new medicines to test their safety and efficacy to ensure they are suitable for use in humans.
• Regulation: Regulatory agencies such as the European Medicines Agency (EMA) or the US Food and Drug Administration (FDA) review and approve medicines. They also monitor the safety of medicines already on the market.
• Pharmacovigilance: Pharmacovigilance is the monitoring of adverse drug reactions (ADRs). This involves monitoring, evaluating and reporting adverse drug reactions, both before and after medicines are launched on the market.
• Quality Assurance: Medicines are subject to strict manufacturing standards and quality controls to ensure that patient safety is not compromised by impurities or other substances.
• Risk Management: Risk management plans are in place to identify and minimise risks associated with the use of medicines.
• Training and Information: An important part of drug safety is training healthcare professionals and patients in the correct use of medicines and the recognition of adverse drug reactions. This ensures that patients and healthcare professionals are aware of the risks and benefits of new medicines and can use them safely and effectively.

Regulatory Framework

Regulatory requirements for the safety of medicines vary from country to country.

In Germany, the German Medicines Act (Arzneimittelgesetz, AMG) regulates the distribution of medicines to ensure a proper and safe supply of medicines.

In Europe, the European Medicines Agency (EMA) uses Good Manufacturing Practice (GMP) to regulate the minimum standards that pharmaceutical manufacturers must implement in the production of their products. It also regulates pharmacovigilance through its EU Regulation No. 726/2004. This sets out the rules for monitoring medicines in the EU and requires companies that place medicines on the market to set up a system to monitor the safety of medicines.

In the US, the Food and Drug Administration (FDA) is responsible for drug safety issues. Internationally, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) provides guidelines on drug safety.

Requirements for a Career in Drug Safety

A career in drug safety usually requires a university degree in pharmacy, medicine, biochemistry or a related field. A Master’s degree or PhD is an advantage. Experience in the pharmaceutical industry and clinical research is often required. Good knowledge of pharmacovigilance, pharmacology and toxicology and experience in dealing with regulatory authorities such as EMA and FDA are also desirable. Basic knowledge of the regulatory framework for drug safety is required.

You must be able to communicate medical and scientific issues clearly and concisely, both orally and in writing.

Analytical skills are also essential to analyse data from a variety of sources, identify risks and make appropriate decisions.

Tasks in the Area of Drug Safety

• Recording, medical-scientific evaluation, display and documentation of all reports of drug risks
• Manage safety databases and electronic case reports
• Recognising and managing risk signals
• Coordinating and, if necessary, preparing periodic safety update reports or similar reports
• Coordination of benefit-risk assessment procedures
• Management of clinical trials
• Preparation and co-ordination of risk management plans
• Preparation and coordination of information materials
• Assisting in the preparation of expert and product information on medicinal products and medical devices
• Preparation of drug safety inspections
• Liaise with drug safety authorities

Are you looking to recruit in the field of drug safety or would you like to develop your career in this area? Contact us and we will find the perfect match for your individual circumstances.