Safety physician careers in the biotech industry
Can you provide a general overview of your job?
I work as a Safety Physician at Amgen. As part of the Safety Team, we evaluate drug performance and make sure that the patients’ safety gets priority.
Any medication has side-effects or adverse events associated with it. No medication is perfect. We need to make sure that none of the adverse events are life-threatening, are causing problems to the patients, or putting the patients at risk.
I work in the cardiovascular therapeutic area. Currently I am responsible for the safety profile of two products at different stages of development, both targeted towards patients who are dealing with heart failure.
Can you give examples of some typical day-to-day tasks?
The job is similar to working as a doctor and meeting patients at the clinic. But instead of sitting face-to-face with a patient, I receive datasets with information from thousands of patients receiving a particular drug treatment. Based on this data, I use medical knowledge and research techniques to analyze whether the benefits of the medication outweigh the risks.
We are obligated to report any adverse events to regulatory agencies such as FDA and also author the safety section of the periodic reports that we send to such agencies.
What are the technical and non-technical aspects of your job?
For my specific job as a safety physician, there are many technical aspects involved. Safety in general is extremely regulated. As much as using your technical knowledge to interpret the data is important, there are also regulations and specific procedures in place at the company that you need to follow. Accordingly, having the necessary knowledge and doing lots of reading to keep up with the new regulations is very helpful for my role.
What are the main skills you learned in grad school that help you be successful at your job?
For this specific job, I have a suitable background from my medical degree, as well as my research PhD. This job requires a medical degree or at least deep experience working with patients to understand the data and what adverse events are involved with the subject.
Some important skills I learned in grad school include how to run a clinical trial, conduct a study, collect the data, understand protocol deviations, run the lab, as well as other basic information and understanding of the data from a safety standpoint. You cannot do the job just by looking at the data, it is more important to know how the data is acquired and what was the narrative for each patient
Conversely, what are skills that you had to learn on your own, since they are not traditionally part of the academic training?
There are lots of aspects including FDA, EMA, and other regulations that you do not learn in grad school regardless of your degree. You learn these rules in your job and it is crucial to follow them strictly, particularly in the biotech and pharma sectors, where companies are inspected regularly by the regulating agencies.
Also, procedures for running a study are much more rigid in industry compared to academia, with less flexibility in deadlines and products. Sure, in academia, you cannot make mistakes. But in industry, mistakes have much larger consequences.
Your job requires keeping up with deadlines and regulations in a high-risk environment. How do you compare the stress levels in your current workplace to grad school, which as we all know is very stressful? How do you personally cope with the stress?
As I just mentioned, mistakes in industry have huge consequences, and as such one would think that the stress levels in industry would be higher. But my experience has been different. Of course, I am still new to my job and I still have a lot to learn, so there is some degree of stress. But I find this job more peaceful than my time in grad school.
As a grad student, you think that everything in your life is attached to your success in grad school, which is actually true to some extent. Especially as an international student, your visa is tied to being grad school, and losing your position can lead to losing your visa status. Your paycheck is also related to grad school, and it is not easy to switch from one university or program to another. Also, you are worried about finding a job after you graduate and transitioning from a student visa to a work visa. So there are many factors that contribute to mental health problems and high stress levels…
For all these reasons, my stress levels are lower now as a working professional compared to when I was an international grad student.
What advice would you give to grad students who are interested in similar careers?
Working in pharma and biotech is very exciting. We have people from different backgrounds such as toxicology, microbiology, genetics, computer science, and even law. We do all sorts of research from cell culture to pre-clinical to clinical, from phase one and filing to phase four and post-market products.
If you have the opportunity, reach out to connections, and try to do an internship to get a first-hand experience of what the job is like. It’s a very fast-paced environment and not everybody will enjoy it.
This job suited me well because I was looking at a job that leverages my medical and research backgrounds. No matter what background you have, you still have a chance to find a job in biotech, which is great!