This week we are wrapping up our Second Year Fellow interviews with one final interview with MCPHS/Sanofi Genzyme Pharmacovigilance fellow, Hayk Krikorian! In addition to the fellowship, Hayk is also our PR Committee Chair and manages our Facebook, Twitter and Instagram (go follow us!) At the end of his first year, we asked him to talk about what he does in pharmacovigilance, what he’s learned after a year as a fellow, and how to be the most competitive applicant at Midyear.
What attracted you to industry?
Throughout pharmacy school, I had been working as a pharmacy technician then interned at CVS. To be able to learn about drugs and be comfortable with the drugs, I think that was a great experience. Throughout my rotations, I was able to have roles in different institutional and clinical settings—in a hospital or a clinic. The only other piece that I feel like I didn’t get through pharmacy school, in terms of direct experience, was industry.
I knew that Cambridge was a big hub for biotech, and I had a few friends who were upperclassmen who knew about industry and were interested in applying for a fellowship. I think that third or fourth year, I really started to research and get it into my head that there’s this third option called the “pharma industry,” and that the fellowship is something that is attainable and within my reach. I attended a professional elective called “The Fundamentals of the Bio-Pharm Industry,” which I’m actually teaching at [MCPHS] Worcester. The course involves fellows coming to teach about their functional areas, so you really get nice exposure to all the different functional areas, and you get to hear first-hand from the fellows.
I think that [the course] was very instrumental in determining what I wanted to do. Specifically, pharmacovigilance was an area that really resonated with me when I was attending the class. Listening to how a pharmacist can make an impact on the patient’s safety—for a product that is given to tens of thousands of patients worldwide, I think that impact really resonated with me. I think that it was a perfect fit for a pharmacist; in particular for what I was interested in and my experiences at CVS where you’re trying to protect the patients that you serve in your community. Now I was exposed to an area where you’d be able to have an impact on a global scale, and that was really intriguing to me.
You mentioned that you are a pharmacovigilance fellow, could you give a summary of what your fellowship position is at Sanofi Genzyme, and what you do day to day?
Pharmacovigilance is basically drug safety. What that means is that this department is responsible for the overall benefit-risk profile for our medicinal products—both in clinical settings and in post-marketing. When you are conducting a clinical study, whether it’s Phase I, II, or III, you are randomizing and controlling all the variables that you can, so that the adverse events you end up seeing can be attributed the drug and not some outside source.
You’re building the risk profile for the drug in your clinical studies—you’re starting to see a lot of the common side effects. Once you have a good idea of the safety profile as well as the efficacy of the drug, you apply to the FDA (Food & Drug Administration) or whichever regulatory body you’re seeking approval. You submit your data, and once it is approved, and you’re in the public marketing phase, you’re not done with the safety portion. You’re continuing to monitor that benefit-risk balance, which changes very dramatically within the first few years of the product being on the market. Now you’re giving [the product] to a lot more people of various backgrounds—ethnic backgrounds, co-morbidities, and different medications they’re on—you’re starting to get a lot more rare adverse events pop up.
In the fellowship, especially here at Sanofi Genzyme, we start in the post-marketing setting. We are assisting and shadowing one of the pharmacovigilance scientists who works here at Genzyme. Among other things, the main thing we do is look for signals. A signal is a new adverse event that not on our product label. It could be serious or non-serious, but we feel strongly based on the case reports that come in from pharmacists, doctors, patients, nurses, that it could be attributed to our drug. We look at it collectively as a company and the FDA, and if we feel strongly that it is attributed to our drug it could be added onto our label.
This fellowship is training you for the pharmacovigilance scientist role, and because one of the main activities we do is signal detection, you are reading cases. What I mean by cases is like in pharmacy school, where you have a pharmacotherapeutic case. You’re reading through the patient’s information, the story of what happened, their past medical history, any concomitant medications, family history, and then determining whether the drug really caused that reaction, or is there something else going on. A lot of the times, the data is very messy, so it’s kind of like a detective game.
You said that for this fellowship, you start in post-marketing. But for a pharmacovigilance team or department, when do they start getting involved?
We start getting involved pretty early. It obviously differs company to company, but we are involved in Phase I; once they’ve identified the drug candidate and then moving on to testing in humans. The first human studies—that’s when pharmacovigilance would get involved.
What would you say are the most important skills required by your position?
Having a keen sense of attention to detail is really important. One word in a report could change the outcome. Being able to really scan through and use your clinical skills—have that attention to detail and perspective—I think that’s really important.
Taking a step back in general to industry, time management is very important. You have different tasks with different deadlines. It’s not like in school where you know exactly what to expect. Once you’re in the real world, you start to have random activities pop up that might trump the priority of what you’re working on. Being able to finely balance long-term projects with short-term projects and manage your time appropriately is really important. I think that’s one skill that school doesn’t really teach you—you kind of have to develop it on your own. Everyone has their own system. Some people use software to remind them and create a calendar, other people need to write it down physically, but figuring out what you need to do in terms of time management is paramount.
Lastly, a lot of the soft schools that you don’t learn in school are super applicable and transferrable to any role in the industry. Being able to effectively communicate verbally and written, and just in general, having people skills—to be able to work in a team, be able to help. Everything is very team oriented, so the more you offer your help, the more that you are engaged with different teams, you start to develop those skills more rapidly.
What do you find most challenging about your position?
Going back to time management, there will be a project that I have—signal detection, for example, that I will be working on for three months. Randomly the FDA or the EMA (European Medicines Agency) will ask us a question and say, “tell us more about your product.” We would have to drop everything and answer their question because there is a 30-day deadline for most of them and steep penalties if you don’t meet it. If you’re not ahead in whatever you’re working on, in terms of the long-term projects, then that might get penalized as well. Time management is the biggest challenge that I am continuously learning and haven’t mastered yet.
What advice would you give to a prospective applicant?
In general, when you’re in pharmacy school, having varied experiences is great. Any work experience you can get is really vital. It shows that you’ve taken that step outside of your studies to engage in a real world scenario where you’re dealing with patients or healthcare providers. If you have any team projects, really taking initiative and being the team leader, that will teach you about working in a team and leading a team. A lot of the questions we ask in an interview setting are team based. It could be like, “if you had a disagreement with a team member, how did you resolve it, and what was the outcome?” I think engaging in teams in school, having real world experience, and if you’re able to have research experience, that really helps.
I think that research is another great thing that you can engage in as a pharmacy student while you’re in school. For myself at MCPHS [University] Boston, we have this program called SURF, which is the Summer Undergrad Research Fellowship. I did that in my sixth year, so right before my rotations started. I took two off-blocks (summer semesters) to engage in research for medical history. That was a three or four month endeavor where I had a research poster, and I was able to print out a small-scale version of the poster to bring to interviews.
Networking—the bigger your network is, the more opportunities you’re going to have. Make sure that while you’re in school, you are forming connections with your professors. You should have at least two professors you would be comfortable asking for a recommendation for applying to a fellowship. In general, the more people you know and the more people you’re in touch with, puts you in a good position when it comes time to apply for a fellowship. Also, if you’re really interested in industry and you are applying for an industry fellowship, talk to the fellows. If you have any contacts or information to any fellow, schedule a 30-minute call with them. Based on what your interests may be, they could put you in touch with another fellow and the list goes on. I talked to a lot of fellows before I started applying, so I would have a good idea of why I’m applying for a particular role.
Another thing that just popped into my mind is to limit your fellowship endeavors to a maximum of two different fellowship areas. Just because you want to get a fellowship and you want to be in the industry, you shouldn’t apply to five different areas. It shows that you’re not focused, and it shows that you don’t really have a good idea of what you want to do and why you want to do it. Having the reasons of why you want to apply to something and limiting it to two functional areas is my last suggestion.
Looking back on your first year, what are some of the lessons learned about being in a fellowship or being a pharmacist in industry?
I definitely recommend advocating for yourself. There are a good number of pharmacists on our team and in industry in general, but [I mean] displaying the value of the fellow, and what it means to be a fellow. Always asking for more projects—the more people you can help the better you name will be in the office. Making sure that you are a dependable person who can meet deadlines and a person someone can depend on if they need help with something. A big lesson is that if you don’t know how to do something—and chances are you won’t in the beginning. Everything you’re exposed to [at the fellowship] is brand new, and you didn’t learn it somewhere [previously], so always make sure to ask questions. Ask questions with your preceptor, whomever you feel comfortable with—if you have a mentor, make sure to ask them early on and not wait three weeks into the project to ask a very basic question.
Hayk Krikorian, PharmD, is a Global Pharmacovigilance Post-Doctoral Fellow with MCPHS Univeristy and Sanofi Genzyme.