Drug Safety
Drug Safety (also known as PV, PhV or Pharmcovigilance) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects to pharmaceutical products or any other drug-related problems.
WHO established its Programme for International Drug Monitoring in response to the thalidomide disaster detected in 1961. Together with the WHO Collaborating Centre for International Drug Monitoring, Uppsala, WHO promotes PV at the country level. At the end of 2010, 134 countries were part of the WHO PV Programme. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines.
Pharmacovigilance focuses on adverse drug reactions, or ADRs, which are defined as any response to a drug which is noxious and unintended, including lack of efficacy. Information received from patients and healthcare providers via pharmacovigilance agreements (PVAs), as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place. In order to market or to test a pharmaceutical product in most countries, adverse event data received by the license holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority.
Ultimately, drug safety is concerned with identifying the hazards associated with pharmaceutical products and with minimising the risk of harm to patients. Companies must conduct comprehensive drug safety and pharmacovigilance audits to assess their compliance with worldwide laws, regulations, and guidance.
Pharmacovigilance or Drug Safety applies to all licensed products while one of the purposes of clinical trials is to identify and record adverse events accessing if the benefits of the new drug outweighs the side effects.
Skills and Experience
- Usually graduate level or healthcare professional
- Working knowledge of ICH regulations
- Awareness of current treatments, practices and safety issues surrounding pharmaceutical product
- Experience of drug safety databases
- Experience of accessing, interpreting and recording adverse event reports including coding medical terminology
- Experience of processing adverse event reports
- Experience of Periodic Safety Reports such as DSUR, PSUR, PBRER, ASR etc
- Experience can be gained in pharma company or CRO environment
Salaries
An entry-level role, usually called a Drug Safety Officer, typically pays around £19k - £22k. Once you have gained some experience, the career development path in this sector can be quite rapid, progressing up to £40k+ (especially in a Big Pharma environment). There is also a buoyant contract market in this area, with hourly rates that are often some way in excess of a permanent salary equivalent.