Clinical Safety Scientist 2

Clinical Safety Scientist James


Clinical Safety Scientist

The industry is so vast that I soon realised I could take my career in so many directions. James

So, what do you do?

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.

What does your typical day involve?

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.

Do you work mostly on your own or as part of team?

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.

How long have you been in your current role?

5 months 

What qualifications and experience do you have?

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 and why did you decide on a career in the Pharmaceutical Industry?

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.

How has your career developed since you left university?

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.

Do you think additional qualifications or experience would be an advantage for someone entering the industry now? 

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. 

What is it like socially where you work?

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.

What are you most proud of in your career? 

Studying for my MSc while working.

What possibilities are there for your career in the future? 

I hope to take my MSc into a PhD.

What do you think are the most important skills for someone in your role to have?

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.

What one piece of advice would you give to someone seeking a career in the pharmaceutical industry?

Experience is key and using that experience to shape your future.

Last modified: 20 September 2023

Last reviewed: 20 September 2023