Vinil Transitioned From Overseas PV Roles To North American Market Success After Gaining Crucial Regulatory Knowledge Through The CCRP Course.

In preparation for further accreditation for CCRPS, we are conducting case studies with graduates to discuss their experience in our course in 15-30 minute interviews with our clinical research educator, Courtney. We invited students to share their feedback asking extensive questions on why they chose the course, what they felt while taking the course, and how the course has helped them after completion. Today, we share Vinil's feedback highlights the CCRP certification program's effectiveness in providing comprehensive education in pharmacovigilance and clinical research, tailored to the needs of professionals transitioning to the North American healthcare sector. His successful application of course learnings in securing employment underscores the practical value of the program. Vinil's suggestions for including more regulatory comparison could help further tailor the course for international professionals.

Key Takeaways

● Vinil appreciated the broad understanding of pharmacovigilance (PV) and clinical research that the course provided. It helped him connect his previous truncated job roles into a coherent whole.

● The course content was instrumental in helping Vinil transition to the North American job market, particularly with knowledge about PV processes in North America.

● The course content directly contributed to Vinil securing his current role, allowing him to effectively discuss industry standards and processes during job interviews.

● Vinil valued the self-paced, online format of the course, which was crucial for managing his schedule as a newcomer to Canada.

● Vinil would recommend the course to others, especially those new to North America or transitioning roles, due to the course’s comprehensive content and flexible format.

Professional Impact and Course Utilization:

● The course significantly boosted Vinil’s confidence in job interviews by providing him with the necessary terminology and concepts relevant to North American standards. This knowledge was directly applied in interviews, helping him articulate his skills and understanding of the field.

Learning Platform Experience:

● Vinil found the learning platform easy to use and navigate. The ability to download materials and access the course content flexibly was particularly beneficial.

Favorite Course Elements:

● Learning the end-to-end PV process was particularly enlightening for Vinil. He enjoyed how the course detailed each step of the process, which enhanced his understanding of his role in the broader industry context.

Content Satisfaction:

● The course met Vinil’s needs perfectly by providing detailed guidelines and regulations for FDA and Health Canada submissions, which were crucial for his career transition in North America.

Website and Support:

● The website was user-friendly and informative. Vinil utilized the chat feature to get immediate answers to his questions, enhancing his enrollment experience.

@0:00 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Meeting is being recorded. Once again, thank you for meeting with me today, and it's a delight to have you here. Congrats on completing the CCRPS program, and I'm pretty much just going to go through question and answer a soft conversation, just to hear your feedback and your experience with the program. So, once you're ready, get into it."

@0:20 - Vinil: "Yeah, sure."

@0:22 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Perfect. Could you share some of your favorite moments from the course that enrich your learning experience?"

@0:28 - Vinil: "Yeah. So, I did work at a PV level, you know, at my previous organization, but then it was always truncated. The information given to us was always limited to the job at hand. So, I was initially in triage. I was a researcher first, and then I was in triage, and then I was in with the ICSRs and individual case safety processing. But the course really helped broaden my view on all that was going on. Yeah, I got to find out what happens, you know, after a case is processed, you know, how it helps in signal detection and how it, you know, participates in generating a signal and the safety limits and how it goes on into the PSERs and PADERs. Because this information was always, you know, it was always on the need to know basis, you know, when you work within a team, when you work with other doctors and whatever it's always also this happens there and this goes on this way. But then with the course, everything was so structured. So I got to see, you know, where my role comes in as a PV professional, as somebody dealing with whatever adverse event and it gave me a very nice perspective start to finish on what happens. I was very thrilled with that."

@1:42 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, good. So it gave you a more, I guess, broad and full circle of how everything is working together. That's good to hear. What sort of program were you looking for when you chose CCRPS and were you pleased with the content of the course once you got started?"

@2:00 - Vinil: "So, the CCRPS was exactly what I was looking for because I moved countries recently, and previously I was back home in my home country of India, where things work a little differently over there. When I first came, I moved to Canada two years ago. I wanted to have an idea of how the North American markets work, what they look like, what they expect from an interviewee. So, the program with the CCRPS really gave me an idea, especially with regards to submission guidelines, what submission timelines are with regards to Health Canada, it is with regards to the FDA, so this is exactly what I was looking for. I was looking to find my footing in sort of the PV scope in this part of the world, and it was exactly what I wanted. It gave me a very nice understanding of how things are done, and I was very informed once the course was done."

@2:58 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, that's a really good thing. Is there any aspect of the course that you feel could have enhanced the learning experience to be more rewarding?"

@3:07 - Vinil: "I don't know if I can honestly answer that question because, again, coming from a research background, I had an idea of most of the things, but then I never knew where it fit on the grand scale of things. Because, again, when you work with a corporation, your role is always truncated, and your role is always directed towards what you're doing, whatever task is assigned on your hand, that's what you focus on. So the course really opened things up, so I don't know if there's anything more that I would have wanted from the course itself."

@3:41 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "I don't know if that's the answer you're looking for. No, I think anything that you're Yeah, because I got a very broad perspective on, so because there were lot of case studies as well."

@3:52 - Vinil: "Remember, towards the end, know, they had case studies, it was very informative, so I don't know what I would want more. Yeah, I don't think I can answer that question up because I don't allow out of it. So I don't know about my question too. And so that maybe in a few years to come, I should be able to answer that."

@4:09 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, well, good. I feel like even if, I mean, if you were saying that you had everything that you needed, then I feel like that's still good feedback. Absolutely. Or if they're looking to add anything, maybe it's already where it should be. So, always good. Were there any additional topics or elements that you wish were included that could have further elevated your understanding?"

@4:33 - Vinil: "So, the course was very, you know, very uniquely structured and that it started with the history of pharmacovigilance and it went into what kind of jobs we can look at and what roles are and, you know, and what are the median lines for what we ought to do. So it was very well structured that way. I think, and again, I wasn't professional. I just that I wasn't aware of how it occurred, just part of the world. I guess. maybe some sort of some sort of a bridging program where they helped you know just especially from participants who are coming from different countries because we we have different supervision guidelines in different countries like so if it could maybe bridge the gap between what we I know it's kind of a you know broad range just to zoom okay these are the kind of students we're going to have but if something if it could bridge between you know the FDA and and have Canada and whatever we did you know probably make the process a lot more I guess streamline in that sense as in so I would know okay with regards to the Indian submission this is what I did and this is what you know I have to do with regards to the FDA submission these are the reporting timelines these are the reporting failures so maybe that alone I guess okay so more of like a global um yeah you know because I mean at least from most of the reviews when I read I mean a lot of them were were agents who had previously worked in you know out of APOC So it definitely will suit, you know, once you target it towards a global audience, I think it definitely would help, yeah."

@6:09 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, perfect. And when you were considering enrolling, was there any specific information on the website that could have better highlighted the benefits of the course?"

@6:21 - Vinil: "No, I think, I mean, I just read a lot of the testimonials, I read a lot of the And yeah, I was really happy because I was looking at a few other programs. was looking at a few universities where they did the exact, you know, I mean, that's what they said that they would do. And no, I got, I got all the information from the website. And I was able to speak to somebody, you know, on the, on the chat. And I was, I got a few questions. wanted to know how they would go about doing this. And yeah, I was, I had all my, all my questions answered. So no, I found the website very, very convenient to use and very informative. I was able to make a decision. And I think, I think the Third day after I looked up on the website, I joined."

@7:03 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "was like, okay, no, I'm game. Yeah, that's great. Would you consider revisiting the course for a refresher? And is there anything that you would want to see within a refresher course?"

@7:16 - Vinil: "Yeah, that is interesting. Yes, I would consider revisiting the course. I already have some of the PDFs was originally offered as well, but especially with regards to progressing and moving forward, moving from just your individual case, if you're processing to moving towards different roles to help with working and offering payders or PSURs, if anything is available on that sort, yeah, would definitely want to revisit the course again, if I can get a little more information on that. Because what I did as well, you know, when I was interviewing and once I was done with CCRPS, This is what I said on my interviews is that, you know, though I have not been technically trained on these things, I'm aware of these things because of the second program I got to CCIP, yes. I did mention it on every interview. So and I'm also, I think my last interview, the hiring manager said, okay, I'm glad that you know these things. So it's going to be easier when you hit the ground running."

@8:21 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So in that sense, yeah. Good, good. I feel like it did give you a good broad, I guess understanding of everything. then you'll be able to apply that to wherever. Okay, if someone from our program were to ask you for recommendations for future editions, such as the 2025 one that is upcoming, would you be open to sharing a list of recommendations?"

@8:48 - Vinil: "Yes, yeah, absolutely."

@8:51 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Okay, someone would be in touch about that. And then that would, if they were to use it, then you would be considered like a contributor to that edition set. It's not as sure comfortable with that, perfect. Could you share what factors motivated you to choose this course and how it set out from other options that you might have considered?"

@9:10 - Vinil: "Yeah, sure. So the first thing, I think, as opposed to any other regular university, like a physical address, I was very glad that CZF was available for me to do online, offline, not to demanding because I was, like I said, I was a newcomer, so I was between jobs and between interviews and just handling things on the domestic level, and I was a newcomer to the country as well, right? So, so many things. I was just happy that the program was accessible, I got all the source material, I got the individual quizzes that I had to do, I was given a deadline for that, and I had enough time to prepare to study up and to, you know, to make myself sure that, okay, these are the things that I know. This is what I'm going to do. It was very accessible that way. So for somebody who is busy and for somebody who wants to upscale and he was busy working and wants to learn more, this is the perfect course because when I looked at many other universities, local colleges as well, it was too much of an ordeal. Like it was okay, you have to be seven hours, you have to be here, you have to go talk to this person and do that. So the fact that it made everything approachable was definitely a huge feather and it was a huge benefit. that the structure was very, very reasonable as opposed to a lot of the local colleges, even university, local colleges over here. That was another thing that I was very grateful for. just charged it to my card and did like I think a four-month installment."

@10:51 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "was really happy. Yeah."

@10:52 - Vinil: "It just meets all the criteria."

@10:54 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "it's all of your boxes and that's perfect. That's perfect. Could you share about your professional journey prior to embarking on the course and how you envisioned the course would contribute to your career prep?"

@11:08 - Vinil: "Yeah, so like I said before, I was completely unaware from a North American, from how PV was being directed and how it was working. So I'm so glad that once I was done with the course, I was able to apply for, because the course also towards the end starts giving you ideas and what kind of roles you can apply for and what kind of qualifications you need and gives you an idea of how to use those words. So I did use lot of those words, I did use a lot of those terminologies. And so when I was just applying, it was not just willing, I was not just applying to anything I could find. I was looking for specific roles, coordinator roles or roles that involved analyzing and processing information. So that was very beneficial that I got out of the information that was given towards the end of the course. So that was a big help and what. What it also gave me was so when when I was interviewing with a lot of the managers when I this is what I said the verbatim Well, I have not worked You know with regards to health Canada submissions or the FDA submissions. This is what I gather. These are the this is the information that I've gathered This is what I know of what happens Yeah, these are the kind of these are your submission protocols These are these are the submission timelines and I've gathered this because of the course that I did so It worked, you know on a two-prong level in the fact that I knew these things and In the in the interim, you know, as I said mood or whatever. I was not just sitting, you know sitting idly I was doing certification So that really helped and I got called back by the same manager for two different interviews because of that Okay, yeah about 30 people who interviewed but because of that I was called back for the second time I don't you know, my the hiring manager remember me and said I remember you You know, you mentioned on the first interview and then can you speak more to that now? I did. And yeah, that's the job that I'm working on right now."

@13:03 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So that's really good to hear."

@13:05 - Vinil: "Yeah, absolutely."

@13:06 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, you were able to apply it and it got you the job, it sounds like."

@13:10 - Vinil: "So that's that's awesome. Yeah, it was a wait, but, you know, for the same manager to have called me back like two months later and to interview me again was, you know, something had to stand out. And the fact that I said, you know, as much as I'm a newcomer and I've never worked, you know, this front, this is my knowledge of of such and certain that I got this from the court and certification that I did."

@13:32 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "So yeah, weapons using. Yeah. About how long did it take you to complete the course to absorb the knowledge? And then do you feel like the duration was adequate for your learning?"

@13:45 - Vinil: "Yeah, that's a good question. So because I am from, you know, research in a PV background, I had, you know, idea of most of the things. So I think I spend a total of, I guess, 10 days, okay, just me studying and going through it. I mean, if you're really going to be taking your time, it should probably be two to three weeks or maybe a month, because I already had a working idea of most of these things. I was able to, you know, accelerate and go through the course material. And because, you know, I have this, I knew what the CTCA was, and I knew what the scoring was like. So I was able to move through quite quickly. I mean, I took about 10 days and that was, and again, like I said, I was managing, I was bouncing between two jobs and taking care of things on a messy front. 10 days was, was, was very comfortable for me to work with. So yeah, I definitely said, so if somebody is from, from a COVID as a background, or from a clinical research background, maybe two weeks is that is a good enough time to go through the material and to get as much as you can out of it."

@14:46 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Right. And the fact that it's self-paced, I feel like helps to just figure schedule and you're able to use as much time as you want to there."

@14:54 - Vinil: "So that's, yeah, absolutely."

@14:57 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "All right. After completing the course, how did do you update your resume to reflect your newfound skills and knowledge and how has it enhanced your professional profile?"

@15:07 - Vinil: "Well, first and foremost, I made everyone know that the identification was completed. I put it up on LinkedIn and that was one of the first things that I did to show them that, you know, within the time that I had these are the these are some of the things that I did. And I also started altering my resume and my CV to let them know that, you know, besides whatever responsibilities and duties that I had, my my general knowledge of certain such things, you know, again, like I said, you know, the submissions or whatever was was up to date because of the, you know, certification that I did, I had hands on access to most of the databases, the safety databases back home. But that was, you know, the chink in my armor, the fact that I was not aware of certain things. So on the horizon, I've mentioned, you know, after the certifications that this is the general, you know, knowledge of things that I've gathered over the period of time, and that I had. which was because of course so that's how I put it on my resume and even on my telephonic interviews and my live interviews that's what I said."

@16:08 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah that's awesome I feel like you really you've had a good experience at that for sure."

@16:12 - Vinil: "Yeah and it also helped because I'm technically not in a health care professional you know I'm not I'm not from a head CP background I'm from a research background so I've been one of my interviews when you know I was asked point you know point blank do you think you can serve you know because you're not from a health care professional background but you think you can serve at this level and these are some of the answers that I give that you know it's because of x y and z and then because of my knowledge of this this and this is that I'm confident that I'll be able to serve so I was able to say all of that because of what I've gathered and what I gleaned."

@16:44 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "that's amazing it definitely helped with your transition into the field."

@16:49 - Vinil: "Yeah how would you describe your experience with our learning platform and did it facilitate a smooth and engaging learning process? Absolutely the platform is so was very easy was very easy to navigate and to go through it was not with the UI was amazing and you know the PDF forms it was it was downloadable so I could read so sometimes what I do is I download a few of the PDFs and I would take it on my phone and if I had long bus journeys I would just sit on the bus and just go through some material like driving up to an interview or back so it was very I should say it was very open it was very user friendly and the point of the course was not to stun inflammation or to keep it protected or just cover it up which unfortunately most of you know when you work at major organizations it's everything in document controlled and it's only on a need to know basis so this was very in that sense so yeah it was very very accessible accessible is is the accessible and user friendly that would bring up yeah awesome I know you kind of touched on this but can you share how the course boosted your confidence

prepared you for job interviews and career advancements in clinical research? Yeah, so I mean, I felt like I got new shoes on, you know, once the course was done.

Okay, I found my footing. This is exactly, you know, this is to bridge the gap between my overseas experience from back home and what I can offer any company that would hire me.

So at this point, I'm working with a patient support service system. So because of my understanding of, okay, these are the regulations and the guidelines for FDA or Canada, I was able to do really well on my interview, you know, with our prior experience in this country, I was able to go and convince my interview managers and the powers that be that I'm a good fit for them.

And yeah, I think it's going to be a year with this company. And I think I got the job.

Let's see, I was done this is your piece in the month of September or October. and it was about four months after that.

yeah, it's been a great 14 years."

@19:04 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, yeah, that's amazing. I feel like it really did. It helped you. It definitely boosted your confidence. And I feel like you were well prepared for your next role for sure."

@19:15 - Vinil: "Yeah, yes, I was."

@19:16 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "What part of the course did you find most engaging and beneficial to your professional development?"

@19:23 - Vinil: "Well, with regards to upskilling, you know, you know, just just the amount of information with with the painters and PSURs and how the safety information that is being collated and collected by different teams, how that goes into just the overall, the life cycle and history of a drug, know, mean, post marketing surveillance, that was the big picture for me. And hopefully I want to get into that role as well, because I've done my due diligence and I've done my put in the hours with everything else, know, started with three hours and everything else. And so now I feel like because I'm a of that, you know, more than just the terminology or what I'm aware of what goes on there. So I'm hoping that I can upskill myself, you know, and start contributing to the overall life cycle of, you know, the safety profile of the drug, now volunteering and by working at those levels. yeah, that's something that I got very clearly from the program. It was not just hearsay or listen a few medics talk about, okay, or that, you know, whenever you're going to submit that. So it was very interesting in that way. So now that I know what kind of role it is and what it entails, and I know what more is needed from me, I feel like I have a better chance of getting it at this point."

@20:42 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah, for sure. feel like it gave you just some interest in something that you maybe didn't know before. Okay, last question that I have for you. What are some reasons that you would recommend this course to others based on your experience?"

@20:57 - Vinil: "Well, because it made my interview process. is a lot more interesting in that I didn't have in that I now had a lot more resource material with me. So I think I would recommend this especially for newcomers who come from Asia-Pacific background and you know when we're not aware of certain nomenclature and certain guidelines that are swallowed and this part of the world. I would recommend that to anyone and everyone who comes there. Even if you do have a pharmacologist's background or research background or whatever it is you in clinical set I would definitely recommend this program just to make sure that you have enough in your quiver so that you can really do well on your interviews and it brings you up to speed when you start fresh as well."

@21:45 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "Yeah okay well that was great I feel like you had a great experience with the program and I can definitely tell just that it's helped you get where you are now and I feel like you had a great success story with it. So I really appreciate your time that you took to spend with me. today and just go through some of those questions. And I know your input and just your experience will definitely have an effect on future learners that are in the program. So I really appreciate you. And I wish you the best of luck in your career. I feel like you have a great understanding of clinical research and it's definitely going to be, you'll have a great career from here on out."

@22:21 - Vinil: "Thank you so much for being here."

@22:22 - Courtney Fulkerson (Certified Clinical Research Professionals Society CCRPS): "All right, thank you for the program as well, yeah. Yeah, well, I will send you an email. You'll get an email by saying with a gift card for doing this and spending time with me. But for that, we are pretty much all set. So I really appreciate you and I hope you have a great day. Thank you, you too. All right, thank you, bye bye."