My Journey in Pharmacovigilance

by Maria Hull

When I joined Panacea in 2017, a year out from completing a BSc in microbiology, I was keen to expand my knowledge of pharmacovigilance (PV). Indeed, a clear pathway for learning was a key factor that drew me to apply for a role as Junior Safety Scientist at Panacea, a Contract Research Organisation (CRO) which provides pharmacovigilance, regulatory affairs, quality assurance, auditing and other bespoke support services to pharmaceutical companies.

I certainly had a lot to sink my teeth into. Pharmacovigilance, being a highly regulated industry, comes with a raft of legislation to ensure specific standards are maintained, with the aim of ensuring the safety and effectiveness of medications. In Europe, this legislation is laid out in the Good Pharmacovigilance Practices (GVP) Modules, which any burgeoning PV scientist will find themselves becoming familiar with in their early months. During my time at Panacea I’ve been lucky enough to attend numerous courses which support my continued learning within the sector; an everchanging landscape thanks to advancements in our knowledge, in technology, and changes to the regulatory framework. Recently, the PV framework has experienced large-scale changes in the face of the COVID-19 pandemic, AI technology, and Brexit. Furthermore, specific areas of PV such as signal detection have changed dramatically with the advent of large data sources, such as those contained in global databases like VigiBase. Signal management processes now harness the power of disproportionality analysis, data mining, and signal management algorithms.

I started my now almost six-year journey at Panacea within the Case Processing team where my role focused on case triage and processing. I quickly found myself taking on additional responsibilities within the Client Support team, with responsibilities including PSMF maintenance and managing client communications. The combination of the responsibilities progressed my understanding of the different components of PV, illustrating how my day-to-day role contributed to the larger ethos of PV in maintaining patient safety. This ethos can sometimes be overlooked in the PV sector. Due to changes in staffing, I took on additional responsibilities within the Quality department, maintaining SOPs. This again gave me another perspective of PV, exemplifying the support functions which are essential in maintaining compliance.

Then, after just under two years at Panacea, I was presented with the opportunity to support the Director of QPPV Services in setting up Panacea’s new QPPV Office. The role involved developing necessary SOPs, co-ordinating Panacea’s network of QPPVs and LRPs, and conducting research to ensure compliance with specific national legislation. During this time, I also received additional training and completed tasks for the RA and QA departments, in the form of maintenance of information on XEVMPD and assisting with due diligence of vendors. This was whilst continuing to provide support where required within the Client Support team (in my role as Deputy Client Support Specialist), Case Processing team (completing case approvals), and Data Evaluation team (completing literature assessments). My role was highly varied and the experiences I’d had so far had given me a broad grasp of PV as a whole. My exposure to numerous teams had also led me to interact with colleagues who had a wealth of experience, be that as longstanding PV experts, those with experience in clinical trials and regulatory aspects, safety physicians, pharmacists, and forensic scientists to name a few. Working with passionate, talented individuals, such as QPPVs who had incredible PV knowledge, I realised I still had much to learn.

Following two years in my role as QPPV Office Co-ordinator I was again presented with an opportunity in the form of a role within the Data Evaluation team as a Safety Scientist. Whilst I had enjoyed and appreciated my varied role up until this point, the potential to expand my knowledge substantially within one area of PV was certainly appealing. There began my path to my current role as Senior Safety Scientist within the Data Evaluation team, which involves completing signal detection and validation reports, drafting and updating RMPs and PSURs, and completing weekly literature assessments, along with a host of varied ad hoc work. I can safely say my aspiration of increasing my knowledge within one area of PV has come to fruition, however I thankfully found I did not have to let go of my varied role. The flexibility which can be seen from my six-year career at Panacea is evident in the work we provide to clients, who can expect bespoke work provided at high-standards. The opportunities for continued growth at Panacea attract, or indeed go on to create, many experts within the field whom I’ve been lucky to learn from.