by Francisco Ferreira
I did not choose pharmacovigilance, pharmacovigilance chose me!
I had finished my studies in Pharmaceutical Sciences and I was able to land a job in the PV department of a consulting firm near Lisbon. I was happy about it since, although PV was not my first area of choice in the pharmaceutical industry at that time, I already had huge respect for it and understood its great importance within the pharmaceutical world. I also liked knowing that my work would have a direct impact on the safety and outcome of patients taking medicines.
However, it was when I had the opportunity to work within the Portuguese Regulatory Authority, Infarmed, that my PV experience increased exponentially. Before this point I had been working in a small PV team, and although we were able to provide entire PV systems to pharmaceutical companies, my work was mainly based at a national level and with generic licences. This all changed when I went to work for Infarmed. Here I started working in a bigger PV team, with a lot more complexity due to the number of people and departments, as well as the different type of medicines that I was working on. It was also a more international environment linking with all the other national EU Regulatory Authorities and the EMA.
My team was responsible for the preparation of the PRAC meetings. I was assigned with a few therapeutic classes and I received different types of report (RMPs, PSURs, etc) from medicines belonging to my assigned classes. I was responsible for verifying that the MA holders had provided all the necessary information and started the process of assessment, sending the report to the respective assessor. Additionally, I also had the opportunity to participate in the review of GVP modules and in answering the questions sent to Infarmed from MA holders and other stakeholders.
This experience allowed me to increase my knowledge and experience in the review of legislation and PV guidance documents, especially in the way that these documents can be interpreted by the different stakeholders. It also provided me with an insight into the concerns that a Regulatory Authority may have when reading/interpreting these documents and providing clarifications to questions.
After a number of years working at Infarmed, I went to work for a CRO (in a project management role) to gain some clinical trial experience. For me, the most impressive difference from post-marketing PV is how in clinical trials we are able to extract more safety information. Everything is generally a lot more detailed. The cases have a lot more follow-ups and it is more unusual that we are not able to know the outcome of a patient. Moreover, the regulatory environment is more complex, not only because clinical trials are quite often run in different countries with different legislation, but also because of the involvement of ethics committees/independent review boards. These factors increase considerably the number of submissions to be made.
More recently, I have started working for a consulting company once again, this time at Panacea Pharma Projects as a contract QPPV. Panacea has surprised me with the high quality of their work while still fulfilling all their timelines. As a QPPV at Panacea I am bringing my expertise and experience to help in the design and performance of our clients’ PV systems.
We can never know the future but it seems to me that PV activities, along with almost everything else, will be affected with new technologies such as Artificial Intelligence and Machine Learning. The promise is that these technologies will be useful in the following ways:
Although these technologies still need to prove their value, it seems that they will be the new source of change in the PV world and I look forward to seeing them develop.