Medical doctors play an important role in evaluating safety during the drug development process. After approval, they continue to have a vital role in detection, assessment, and prevention of adverse effects related to the drug – this is a subset of drug safety known as pharmacovigilance. This article is about how to become a drug safety physician for those seeking a change from clinical medicine or exploring career opportunities in the pharmaceutical industry.
Why would you want to become a drug safety physician?
- It’s nonclinical
- Regular schedule and weekends off
- Good pay
- Opportunity to transition to various other positions within pharma
- Some roles allow for remote work or telecommuting
- You’ll continue to use the medical knowledge and training that you worked hard for
- Your work helps ensure that drugs are safe
Getting into this line of work – as well many pharma jobs – can be difficult without having prior experience in the pharmaceutical industry. But there are ways to gain relevant experience in drug safety without actually holding the title of Drug Safety Physician. Here’s how.
1. Complete a fellowship in pharmacovigilance
A few pharmaceutical companies have fellowships in drug safety specifically for physicians. They are aimed at providing the necessary training for you to excel in a full-time pharmacovigilance position. If you can bear the thought of another year of training, these are an incredibly effective way to get your foot in the door to a drug safety career.
These programs include a New Jersey-based fellowship with Otsuka that is sponsored by the American College of Preventive Medicine and another one in Washington, DC with Vanda. Both of these encourage applicants who are recent residency grads.
You can also look into physician leadership development programs with pharmaceutical companies, which often offer a rotation in drug safety as a portion of the program.
2. Work for a pharmacovigilance service provider or CRO
Contract research organizations (often referred to as CROs) provide outsourced research services for the pharmaceutical industry. Many of them offer drug safety as one of their services. There are several organizations that focus exclusively on pharmacovigilance; however, these appear to be more common in Europe as a result of different safety regulations there.
It can be easier to land a medically-relevant job with a CRO than with a pharmaceutical company. Nonetheless, the drug safety experience you’ll get with a CRO will give you the experience you need to transition to a career with a pharma organization down the road.
US-based CROs offering drug safety services include:
Many EU-based companies also have locations in the US:
3. Take a drug safety job that doesn’t require an MD
Drug safety divisions within pharmaceutical companies are made up of far more than just physicians. Certain positions don’t require an MD. If you’re willing to sacrifice some amount of pay in exchange for relevant experience, taking one of these roles can set you on the path for a pharmacovigilance physician position.
Job titles for these positions include:
- Safety Associate
- Safety Specialist
- Pharmacovigilance Associate
- Pharmacovigilance Scientist
4. Gain experience in a different division within pharma
Relevant jobs for physicians in the pharmaceutical industry span many departments and divisions across a company. You’re likely to get at least some exposure to drug safety and pharmacovigilance with a job in any of these areas:
- Medical affairs
- Research & development
- Regulatory affairs
Moving laterally within the organization is often supported and even encouraged by pharma companies.
5. Work for the Food and Drug Administration
A physician reviewer position with the FDA is an excellent background for a pharmacovigilance career. Pharmacovigilance programs are, after all, put in place to meet FDA requirements. Most positions will require that you live in the Washington, DC.
For those who don’t have the experience or training needed for a full-time physician reviewer position, there are also several FDA fellowship programs that can provide relevant experience.
6. Complete a relevant residency program or degree
Many MPH programs offer courses on the topic of drug safety. If not specifically about drug safety, courses in drug development typically included a component of drug safety. MPH curriculums also include statistics, epidemiology, clinical research and trial design, population health, and other topics that are relevant to pharmacovigilance.
An MPH is not the only masters program that can be a great background to a drug safety career. Various Master of Science degrees will provide comparable education in topics that will make you a better candidate for a drug safety physician position. Consider an MS in a field such as:
- Management of Drug Development
- Clinical Research
Some residency programs will provide similar training experiences. Preventive medicine residencies offer rotations in epidemiology and statistics, with some even collaborating with pharma companies. For other specialties, look for residency programs that include a research component.
7. Freelance as a medical writer
Freelancing in the medical communications or regulator writing spaces, while not directly related to pharmacovigilance, is an avenue that offers a lot of flexibility. Most medical writing work can be done from home on your free time while working another job. By providing medical writing services for pharmaceutical companies, you’re likely to learn about:
- Regulation surrounding drug development,
- FDA submissions,
- Clinical study reporting,
- and other topics that are at least tangentially related to drug safety and post-marketing surveillance.
There are certainly other backgrounds and experiences that will contribute to making you a strong candidate for a physician pharmacovigilance career, as well. For example, being involved in clinical research and publishing. Or serving on your organization’s P&T committee. Don’t dismiss a career pivot to drug safety because you think you’re inexperienced or underqualified!