What is pharmacovigilance and why is it important?
Pharmacovigilance, also known as drug safety, is the science relating to collecting, detecting, assessing, monitoring and preventing adverse effects of pharmaceutical products, allowing us to understand more about their benefits and risks. The aim of pharmacovigilance is to strengthen patient safety through ongoing investigations, identifying and monitoring any previously unknown adverse effects and assessing whether action needs to be taken to improve drug safety.
It is essential for ensuring that any medicines created and manufactured by pharmaceutical companies are effective and do not pose any serious danger to consumers – or if they do, that they are modified swiftly and accordingly.
How is pharmacovigilance done?
Pharmacovigilance begins with Phase I, II and III clinical trials that provide important data about how drugs perform. Within this clinical research, the objective is to establish whether the benefits outweigh the risks in order to allow pharmaceutical companies to gain authorisation to take the products to market for mass use.
Before approval can be given, clinical trials data is shared with the pharmaceutical company (or CRO) in question’s pharmacovigilance team and reviewed. They determine from the data whether the medicine is safe and effective enough to proceed into the next phase of research or to apply for its approval.
Companies also carry out ongoing pharmacovigilance (Phase IV trials) through healthcare professionals and consumers. This is to monitor a product’s real-world effectiveness and continually update its safety guidelines as it is not possible to anticipate all adverse effects through pre-approval studies. This may be done through electronic health records or drug registries, for example.
Jobs in pharmacovigilance
There are a number of job roles that sit within drug safety, each with varying tasks and levels of responsibility. Exact duties will depend on whether you are working within the pre-approval or post-approval stages of pharmacovigilance, and the type of company you are employed by. Some roles you might want to consider include:
- PV Associate – a more entry level role that involves providing support in all administrative aspects of safety information, including capturing adverse event information and entering data from trials
- PV Support – usually responsible for supporting the collection and tracking of PV requirements as well as interacting with vendors to support the handover of PV activities
- PV Manager – generally performs the role of project manager, provides advice on PV strategy and coordinates regulatory documents for products
- PV Specialist / Scientist– involves assessing and processing incoming safety data from multiple sources, entering data and providing information to marketing partners/third-party partners
Types of employers
Those working in pharmacovigilance are employed mainly within pharmaceutical companies, CROs and external regulatory bodies.
To find out who’s hiring right now, search drug safety jobs here.
Qualifications and experience required
To get a job in drug safety, a Bachelor’s degree will usually be required within a relevant subject such as life, health or pharmaceutical sciences. Whilst not always essential, a postgraduate qualification in drug safety or project management may be highly beneficial in securing a role. The University of Hertfordshire and The University of Portsmouth offer PgDip courses that are widely recognised. It is also possible to enter the profession as a qualified health professional (nurse or pharmacist, for example) with suitable medical qualifications.
It is generally fairly difficult to get into high-level pharmacovigilance roles without prior experience, therefore it is essential where possible to gain some form of experience through entry-level jobs or university work placements.
Download CV and cover letter templates here.
How to get into pharmacovigilance
You will need to have a number of skills, including:
- Observational skills as well as attention to detail
- Analytical and problem-solving skills
- Excellent communication skills, both written and verbal
- IT skills
- Team working skills
- Mathematical skills
- Project management and planning skills
- Ability to work in a fast-paced environment
In an interview for a pharmacovigilance job, you are likely to be asked questions that explore your knowledge of adverse drugs and reactions, as well as regulatory bodies, legislation and guidelines. You may be asked “what are the different types of pharmacovigilance?” or “what are data assessments within PV?”. An employer may also want to know about your familiarity with report documents such as the DSUR, PSUR and SDEA. You should always use the STAR technique when answering interview questions, which you can find out more about here.
There are a variety of ways to search for drug safety jobs, depending on the type of company you are aiming to work for. Job websites such as Pharmiweb and Emed are a great place to start, as well as clinical publications. You may also find opportunities listed on professional networking sites such as LinkedIn. Specialist recruitment agencies, such as CK Group, are another effective way to search for and land jobs, as they are able to offer tailored support and advice.
Sign up to CK+ to apply for roles at the click of a button and receive job alerts straight to your inbox here.
The average salary for pharmacovigilance jobs sits at around £40,000 per year, although this can vary depending on the type of company, location and exact responsibilities of the role. More entry-level positions may sit between £30,000 and £35,000, and with some experience you can expect to earn in excess of £50,000.
You may be able to earn more as a contractor.
There are a variety of career progression opportunities, such as:
- Progression into a more senior role – such as Team Lead or Director – that takes on a higher level of responsibility and gives the opportunity to manage teams
- A move into different phases of clinical trials
- Becoming a contract worker