James, Clinical Safety Scientist
I currently process literature articles received by a large pharmaceutical company throughout the world. That involves ensuring the correct details are entered onto the database, the literature article is available for submission and finally logging/submitting reports to regulatory agencies.
My day starts with reviewing my cases to prioritise them based on deadline and then difficulty. I process the most urgent and difficult cases and then submit my report. I then process the cases onto the database, ensuring all details are correct and the correct reports are highlighted. In some cases I will follow up with the reporter to clarify details or with the local company regarding a translation. Once the case is finished I process the next and so on. At the end of the day I quality check my cases and then submit any pending reports.
The processing itself is individual but with literature it's very subjective and so that is where the team comes in. There are numerous coding options and advice is often required from team members, managers and in some cases physicians. Finally submission is a team approach, numerous departments are involved there.
Currently: MSc Pharmacovigilance, University of Hertfordshire
Past: BSc in Psychology, University of Leicester, 2.1
4 A levels
Experience: I worked for a small generic company from graduation before moving to my current company in there literature monitoring and medical information department.
When I left university I realised a psychology degree needed to be extended if I was to carry on in that field. I wanted to keep learning but also move into the commercial market. Working for a pharmaceutical company fulfilled both requirements exceptionally well. My degree in psychology, though it does not naturally lend itself to the pharmaceutics industry, gives me a different outlook and just focuses my attention to specific drugs. The industry is so vast that I soon realised I could take my career in so many directions.
I have been very fortunate in my career and it has developed massively. While at the generic company I was given vast experience. From managing literature for 5 clients and their medical information to being an active member in 4 MHRA inspections. Since leaving that company I have focused my attention from breadth to depth, and the training has been extensive.
Work experience is vital, Harold S Geneen said it best with "In the business world, everyone is paid in two coins: cash and experience. Take the experience first; the cash will come later" that's the pharmaceutical industry in my mind. Gain as much experience in as many places as you can. A year in industry while at university, a summer working as an assistant to a Qualified Person or with a Chief Investigator of a clinical trial is worth so much.
Extremely friendly and supportive. At the generic company we worked as a one man team but at my current company it's very team orientated which brings a framework where everyone is valued and mistakes are accepted and resolved.
Studying for my MSc while working.
I hope to take my MSc into a PhD.
Attention to detail. In all aspects of the pharmaceutical world it's that attention to detail that makes you a success. With a focus on my role, it's ensuring the diagnostic data is correct, and therefore an event is recorded, which can be the difference between a serious and non serious case. That then impacts on reporting, compliance and ultimately safety. So one mistake has repercussions. Not to say that error will not be picked up as the supportive framework is always there.
Experience is key and using that experience to shape your future.