Associate Director Pharmacovigilance Quality Assurance, AbbVie
James had an unconventional and unplanned entry into the Pharmaceutical Industry.
He studied Landscape Architecture and graduated from the University of Manchester in 2006 where he achieved undergraduate and master’s degrees. James worked as a chartered landscape architect for three years before falling victim to the financial crisis in 2009. After being made redundant, James struggled to find work for several months.
In 2010, James was eventually offered a temp position at a large consumer goods company. After three months of performing administrative PV tasks, James was offered a fulltime position in the aggregate reporting team. Over the next two years James held other roles in the PV safety compliance team, primarily supporting the implementation of the Good Pharmacovigilance Practice modules in 2012.
James recognised that to proceed with a career in PV, he would need to obtain further education and qualifications that would support his progression. In 2013, James enrolled on the DSRU post-graduate programme, obtaining his diploma in 2016.
During this time, James attended eight courses: Back to Basics in Pharmacovigilance, Introduction to Pharmacoepidemiology, Medical Aspects of ADRs, Pharmacovigilance Planning and Risk Management, Monitoring Safety in Clinical Trials and Drug Development, Periodic Safety Reports PSURs/PBRERs, Global Pharmacovigilance Regulatory Requirements: What’s New? and Risk Benefit Assessment in Pharmacovigilance.
James remarked that the pre and post-course assignments also provided an excellent opportunity to put newly gained knowledge to the test – with constructive feedback provided upon completion.
In addition to a great range of courses, the programme was facilitated by a dedicated team who provided valuable student support and were on hand to answer any questions and ensure that every detail was covered. Course information was shared via digital platforms and was easy to access.
James particularly appreciated the flexible course framework which complimented a balance of self-directed study whilst working full time. He found having industry experts at the core of the curriculum highly valuable, as they brought practical experience to every course.
The programme was crucial in further expanding James’ knowledge of PV requirements and their practical application in an industry setting. James confidently says that his time studying with the DSRU, and his diploma definitely helped him to obtain more senior roles during his career progression.
After 13 years in industry, James now regularly presents at DSRU courses as an industry expert in pharmacovigilance audits and inspections.