The next time you buy a medication, take a look at the back of the label. Under the title “Drug Facts,” you’ll generally find its active ingredients, uses and a long list of warnings. Keeping an eye on these warnings is important for using medication safely and you can thank the field of pharmacovigilance for that.
“When it comes to drugs, we think of two words: safety and efficacy,” says Professor Sachin Shah, who works with University of the Pacific’s Thomas J. Long School of Pharmacy. “So, safety is half of the equation. And, for that reason, pharmacovigilance—or drug safety—is important.”
Pharmacovigilance specialists and scientists detect, assess, understand and prevent unwanted side effects of medications and vaccines. You may not notice their work, but you benefit from it. From preclinical development to post-release monitoring, pharmacovigilance is involved in every stage of a drug’s lifespan.
The importance of this field is reflected by its business metrics: the U.S. pharmacovigilance market size, which are the total potential revenues in a certain period, was about $2.09 billion in 2024. By 2034, Precedence Research estimates that will nearly double to $5.17 billion.
If you’re interested in a pharmaceutical career, here are some things to know about pursuing jobs in pharmacovigilance.
What is a pharmacovigilance specialist?
Pharmacovigilance specialists may have many different job responsibilities depending on the company. Keep in mind that pharmacovigilance is involved in most stages of drug development, which the FDA defines as a five-step process: discovery and development, preclinical research, clinical research, FDA review and then post-market safety monitoring.
Pharmacovigilance specialists may be involved in multiple steps or focus on a single area. Specialists in the preclinical or clinical research step ensure compliance with company or regulatory policy, assist with safety databases and collaborate with other departments. In post-market safety monitoring, specialists work with safety data to identify trends indicating a drug may have unexpected side effects.
This information is essential to determine if a trend of side effects is caused by the drug, caused by the drug interacting with something else or if another factor is causing it. Depending on their findings, they may update those warning labels or change their usage guidance usage for healthcare providers.
Getting into pharmacovigilance
You might be wondering what degree you should get to go into pharmacovigilance, also known as PV for short. There actually isn’t one “right” way to enter the field.
“It allows you to enter it through many different avenues, rather than having a set pathway,” says Mark Vingralek ‘24, who now works as a pharmacovigilance system solutions and innovations associate for Genentech. “I’ve met tons of different professionals who had very strange pathways to getting into PV. Some worked in academia before transitioning to PV. One was a longtime career nurse and then transitioned into it.”
Vingralek’s pathway into the field was through the life sciences. He earned a degree in cellular and molecular biology prior to becoming a Doctor of Pharmacy, also known as a PharmD, at Pacific. Some universities offer specialized tracks like his degree, while others offer more general biological sciences degrees. Your choice of electives in these degrees can allow similar specialization.
Another pathway into the field is through a pharmaceutical science degree, which focuses on the development and manufacture of new drugs. This can open doors to jobs like scientific research, manufacturing or regulation. It’s also a pathway into pharmacovigilance, which is involved in each stage of drug development.
Sophia Luu ’19, for example, got her degree in pharmaceutical science before earning her PharmD at Pacific. She now works as a pharmacovigilance manager at Corcept Therapeutics.
You may have noticed that both Vingralek and Luu went on to Pacific’s PharmD program, which offers another possibility: a pre-pharmacy advantage program. These programs guarantee admission into a university’s PharmD program and can position you to complete them in a shorter-than-normal timespan. This is an option Shah highlights.
“A good safety person has a good realization of what’s happening in the field as a pharmacist,” Shah says. “You have to do clinical training for at least a year and that makes you very relevant.”
Doctor of Pharmacy program
After you graduate, you can also consider graduate school. While not necessarily required, a graduate education is an opportunity to build more specialized skills, practical experience and professional networks.
Just like for an undergraduate degree, there isn’t one “right” graduate degree for pharmacology. There are pathways into it through advanced nursing, health sciences or medical degrees.
One option, which Luu and Vingralek took, is a PharmD program that teaches you about treating disease through pharmaceuticals, medical chemistry and therapeutics. You develop a stronger foundation in managing clinical cases and learn how to operate in different environments like hospital, community or retail pharmacy.
It’s a common misconception that PharmD programs only train pharmacists for retail settings, which is only one of the options available. Depending on the experiences you get in your program, you can use your specialization in a variety of different areas, including working directly for the pharmaceutical industry.
“Every time a patient gets a drug, a pharmacist has a duty to counsel them on the safety profile and what the benefits are, too,” Shah says. “And that’s why pharmacists are positioned to be good drug safety leaders.”
Important skills for pharmacovigilance
Because pharmacovigilance specialists may play different roles, there are a couple skills you can focus on while getting your degree.
It’s important to have a strong basis in life sciences or the health care field, which is essential for understanding the products and conditions you work with. You can build this knowledge in degrees like pharmaceutical science, biological sciences and others in that realm.
Data analysis and management is also a strong skill to have. Many pharmacovigilance specialists are tasked with managing or analyzing large amounts of data about patients, reports or drug safety. So, it’s helpful to be familiar with database management and data analysis.
That’s some of the work Vingralek does day-to-day, collecting and auditing safety data from post-market drugs.
“We have to analyze all our patient safety data to be up to date with FDA regulations. And another thing we do is look at safety data from clinical trials that Genentech is running, ensuring our patient safety there as well,” he says.
Collecting this kind of data isn’t limited to post-market drugs. Analyzing safety data is also helpful during a drug’s development. This information helps companies determine who is a good fit for the medication.
If you’re looking for pharmacovigilance roles other than specialist, Luu recommends having some project management experience. Pharmacovigilance jobs can be focused on science or operations. She’s worked both and now handles the latter as a pharmacovigilance manager.
“Pharma companies will outsource projects, so a big part of it is actually vendor management,” Luu says. “I know colleagues who did not get a PharmD, but did get into the operational part of PV.”
Finally, as Shah points out, having clinical experience can be very useful. Drug development and clinical trials happen at all pharmaceutical companies, so it’s great to have hands-on experience with that process.
Studying for pharmacovigilance at Pacific
Studying at Pacific, whether for an undergraduate or advanced degree, can help launch your career.
In 2024, Pacific’s Thomas J. Long School of Pharmacy graduates taking the North American Pharmacist Licensure Examination—one of the ways a state’s board of pharmacy determines someone’s ability to practice as a pharmacist—had the highest pass rate in the west. Over 90% of Pacific’s first-time test-takers passed, far exceeding the national average of 77.5%.
Pacific can help you step into this career through a combination of hands-on education and other special opportunities. Having clinical experience, as Shah highlights, is especially important.
One way to better prepare for industry roles is through the pharmacy school’s Innovative Clinical and Outcomes Research Center, known as iCOR for short. There, students can collaborate with peers, faculty and industry pharmacists on research projects and clinical trials. This work has an effect on the world outside of Pacific, too.
“Just this past weekend at the American College of Cardiology we presented a poster on the safety profile of Mounjaro when it comes to the risk of gall bladder diseases,” Shah says.
The school also provides fellowship programs to graduate students, including its Fellowship in Industry program. This fellowship partners with major biotechnology companies to give PharmD graduates experience with cutting-edge pharmaceutical companies.
You can also build connections in school with your peers and through on-campus organizations like the Industry Pharmacists Organizations, known commonly as IPhO. As a member of the executive board, Vingralek says he met and received mentorship from Shah. He also credits his work with shaping his interest in pharmacovigilance.
“I got to meet a lot of different people in different fields,” Vingralek says. “And I got to hear a good earful about clinical operations, pharmacovigilance, what each job entailed and what the work-life balance was like.”
Building these informal networks at Pacific and beyond are helpful for understanding your career options, and they can also help when you’re actually getting a job. Luu got her start in pharmacovigilance thanks to networking.
“That’s actually how I got my foot in the door at Genentech. I knew someone from another PharmD school. They helped me get into the company,” Luu says.
Through a combination of school activities and informal relationships, you can build a foundation for entering the world of drug safety as a pharmacovigilance specialist.
If this sounds up your alley, check out some of the pathways available to you, whether that’s through a pharmaceutical science, a pre-pharmacy or a life science degree.
And while getting a graduate degree isn’t strictly necessary, obtaining something like a PharmD can help you build your resume and professional network. Though pharmacy isn’t the only path into pharmacovigilance, it will set you up to understand the systems and drugs you’re working with.
“People joke that death and taxes are a guarantee,” Shah says. “I sometimes wonder if it’s ‘disease, death and taxes are a guarantee,’ because everyone gets sick at some point. You have to take medications, right? Understanding the safety of medications is very important, so I want to stress the importance of safety and the role that pharmacists can play in that capacity.”