The role varies between companies but typically involves:
- The receipt, processing and reporting of adverse event reports
- Following-up with reporters to obtain further details about a case report
- Providing an information service to healthcare professionals and patients on product safety
- Providing safety expertise to internal cross-functional colleagues
As a manager the role typically involves:
- Having oversight of the day to day pharmacovigilance processes and ensuring they are working correctly
- Attending various safety related meetings (albeit internal or cross-industry)
- Looking at how the safety function can add value to the business
- Providing pharmacovigilance expertise to the management of Patient risk management plans
2. What is a typical day for you?
I’m not sure there is one! For me there are two distinct parts of the safety role – the day to day part of the role (which mainly focuses on the handing of safety reports) and the cross-functional part of the role (which mainly focuses on how the safety function can add value in the cross-functional settting).
The day to day part of the role can be routine but the volume and nature of the reports we receive always presents a challenge to ensure that the reports are processed in a timely manner and to the high standards that are expected. At the same time, members of the team can be working on cross-functional projects with our colleagues in the medical affairs or sales and marketing function, or they can be working on cross-industry initiatives.
3. How did you begin your career in safety?
When I left university I had a short time working at the MHRA (the UK Regulatory Authority) which was a good introduction to the pharmaceutical industry. From there I went onto work within the safety departments of 2 large pharmaceutical companies.
4. What do you enjoy most about your job?
Working with the team to develop them – I am keen that my team should be recognised not only for their safety expertise but the other skills and experience that they can bring to the business outside of safety.
I also enjoy looking at how we can make our processes more efficient so that we can create more time for proactive risk management and activities which focus on using safety data to maximise patient safety.
5. What is the hardest part of your job?
Keeping on top of the legislation- safety is highly regulated buy keeping up to date with the legislation and how it is being interpreted by industry and the various regulatory authorities is a challenge.
6. Why did you decide to pursue this career?
I’m not sure anyone has ever grown up thinking that when they are older they want to work in pharmacovigilance and it was something that I fell into really. However, I enjoyed working within pharmacovigilance and it has progressed from there. The Safety role has evolved over time and working in a culture whereby we are streamlining our processes so that we can focus our energy on using safety data in the smartest, most proactive way to anticipate/identify issues has kept my interest in this area.
7. What can this type of job lead on to?
It depends on the company but likely roles are other careers within Medical and Regulatory Affairs, Clinical Research, Training, Compliance and Auditing.
8. What advice would you give to somebody considering Drug Safety Associate as a career?
There are a lot of misconceptions about safety. There is part of the role which is relatively routine (e.g. collection and processing of reports) but the key is to think broadly and understand the importance of these activities in protecting patients who receive any given medicine. In addition, the key to being successful in safety is to use your safety expertise to consider how you can add value to your business and improve the understanding of the risk and benefit of a given medicine.
If you work in Pharmcovigilance and have anything to add, please do feel free to leave your comments below.