Pharmacovigilance
Pharmacovigilance (also known as PV, PhV, PVG or Drug Safety) 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, WHO promotes Pharmacovigilance / Drug Safety at country level. At the end of 2010, 134 countries were part of the WHO Pharmacovigilance / Drug Safety Programme. The aims of Pharmacovigilance / Drug Safety 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 / Drug Safety 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 / Drug Safety to take place. In order to market or to test a pharmaceutical product in most countries, adverse event data received by the licence holder (usually a pharmaceutical company) must be submitted to the local drug regulatory authority.
Ultimately, Pharmacovigilance / 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 Pharmacovigilance / Drug Safety audits to assess their compliance with worldwide laws, regulations, and guidance.
Pharmacovigilance / 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 required to become a Pharmacovigilance / Drug Safety Professional
- 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
Salary Levels
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 the Pharmacovigilance / Drug Safety area, with hourly rates that are often some way in excess of a permanent salary equivalent.
Scotland
Scotland is a country that is part of the United Kingdom. Covering the northern third of the island of Great Britain.
The global cell and gene therapy market was valued at $6.68 billion in 2019 and is expected to reach $13.23 billion in 2023 at a CAGR of 24.10% (Ref. BusinessWire).Also in 2019, a joint report from The Alliance for Regenerative Medicine (ARM) and the BioIndustry Association (BIA) stated that the UK is a leading source of innovation and development of advanced therapy medicinal products (ATMPs) in Europe. These products, which include gene therapies, cell therapies, and tissue-engineered products, are intended to augment, repair, replace, or regenerate organs, tissues, cells, genes, and metabolic processes within the body. Scotland has a strong reputation in research & translational development in these fields and is rapidly growing a vibrant cluster of spin-out therapeutic companies, increasing clinical trials of new Advanced Therapy Medicinal Products (ATMPs) as well as expanding its manufacturing capability.
Scotland also has established expertise in developing and manufacturinghuman vaccines(the global market projected to grow to $96b by 2023 according to Business Research Company) and animal vaccines (worth $9b by 2025 – Global Market Insights, Inc).
Scotland’s profile and contribution towards the growth of the UK ATMP sector is increasing rapidly. A strengthening supply chain is supporting new advanced therapy applications – fuelled by world-leading academic expertise in cell & gene therapy and regenerative medicine,. With a forward focus on translation, specialised clinical trials, and GMP manufacture and analysis, Scotland is growing a vibrant infrastructure to support end-to-end development of advanced therapies.
Human and animal vaccine development is a strength in Scotland represented by companies such as Valneva, Neogen, and GalvMed as well as the Moredun Research Institute. In addition to Valneva’s Covid-19 Vaccine programme, Scotland’s supply chain made huge contributions to the development of Covid-19 vaccines including Merck BioReliance, Charles River, Symbiosis, SGS, Ingenza & ReproCell Europe.
One of the largest life sciences clusters in Europe, Scotland is home to a range of multinationals and small and medium enterprises (SMEs) with a strong track record of creating and growing startups.
Scotland has comprehensive supply chains and world class manufacturing expertise supplying chemical and healthcare equipment, pharmaceutical services, medicines, vaccines and diagnostics to the world.
The cluster continues its rapid expansion building on a strong industry base, leading universities with a thriving entrepreneurial culture and close collaborations across industry, academia, the National Health Service and government.
Scotland is a great place to further your career in life sciences. If you are a looking for pharmaceutical jobs in Scotland, scientific careers in Scotland or want to discuss cell therapy, gene therapy, ATMP, medical device, technology, biotech or pharmaceutical job opportunities in Scotland, give our Next Phase team a call. The Scottish area is continuing to expand as a centre for jobs in science, process development, technology, software development, project management, informatics, quality, reg affairs and supply chain.
At Next Phase we help people find new jobs in life sciences across the UK, Europe and USA. This page lists some of the job opportunities in Scotland, and if you give us a call we can also talk to you about other scientific jobs, pharmaceutical career opportunities and the latest updates in cell and gene therapy and ATMP development in the Scottish area.
