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Startup Triumph: How SafeVig Revolutionizes Pharmacovigilance

Interview | December 6, 2024

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Discover Ms. Sridivya Palacharla's inspiring journey from corporate to entrepreneurship and insights on SafeVig & pharmacovigilance.

Pharma Now: Welcome to Pharma Now, Ms. Sridivya Palacharla. Thank you for joining us. I understand you run SafeVig, a company that provides pharmacovigilance and technology services. Through this interview, I hope to deliver Pharma Now’s audience insights into SafeVig and you as an entrepreneur. So, let’s start with you. Can you share a little about your experience and your journey to opening SafeVig?


Ms. Palacharla: I always wanted to become a doctor, but my destiny had other plans. Now, I'm an entrepreneur, and I’m working with many doctors, and I’m happy with it. I completed my Master’s in Pharmacology. Then, I worked for several multinational companies and finally started SafeVig. When I was working at my previous jobs, I wanted to influence people and inspire women, especially those from a rural background—because I'm from a rural background. So, I always felt that language or communication gaps hinder me from achieving things. I didn’t want language and communication gaps to stop women from rural backgrounds; I wanted to inspire them. So, I thought, “Maybe this [SafeVig] is a good platform. I can inspire more people by being an entrepreneur than by doing a job.” So, that's one of the reasons I started working for myself. I had the passion to launch my startup, which is now called SafeVig. 


Pharma Now: I think you will inspire many young women–from all backgrounds and countries–to start their companies. As you mentioned, you worked in corporate and multinational companies. How many years did you work in the industry before starting SafeVig?


Ms. Palacharla: I worked in the industry for almost 15 years; I started my career in clinical research and then shifted to pharmacovigilance services. I worked as a project manager, leading big teams. Then, my passion for technology moved me to the technology part of pharmacovigilance. There, I integrated my knowledge in pharmacovigilance and technology. As a business analyst, I worked with different clients. This later gave me the confidence to start SafeVig. That's why SafeVig is into both technology and services, and we provide pharmacovigilance and technology services. 


Pharma Now: Since SafeVig provides pharmacovigilance services, I think you’re the best person for me to ask my next question: What exactly is pharmacovigilance? What is done in the pharmacovigilance stages of pharmaceutical drugs?


Ms. Palacharla: Pharmacovigilance is the assessment of the safety of drugs. So, many drugs enter the market after completing Phases 1-4 of clinical trials. During these phases, patients may face many side effects. We monitor these side effects or any other serious effects and submit detailed reports highlighting these effects to regulatory authorities. Many processes are involved in pharmacovigilance, and SafeVig provides services to help with all of these.


Pharma Now: I think my next question may be a little obvious, but there is a little confusion around the topic I’m hoping you can clarify: Does pharmacovigilance start during clinical trials or after their completion? 


Ms. Palacharla: This is what most people don't know: Pharmacovigilance starts from the beginning of clinical trials, which means it is a factor in Phase 1 of clinical trials, as soon as the drug is tested on people. Plus, there is no “end” of pharmacovigilance. We have to check the safety of drugs during their entire life cycle. 


Pharma Now: Oh, understood, the goal is to ensure the product is safe for people at all stages: from the start of testing to actual consumption by patients. I think you’ve explained this well, and if I’m not wrong, this is where my startup's name comes from: SafeVig meaning Safety and Vigilance.


Ms. Palacharla: Yes, I'm very passionate about my profession, and I'm very attached to the word “pharmacovigilance”. Since the beginning of my career, I've worked in this field. So, I know the different kinds of side effects patients face and the impact we have on their lives as pharma professionals. That's why I named my company SafeVig, which stands for the safety and vigilance of drugs. 


Pharma Now: Understandable. I think your company is still new. So, how old is your company now, and how big is your team? 


Ms. Palacharla: We started SafeVig in 2023; it’s 1 year old now. Today, we are a team of 50, based in Hyderabad.


Pharma Now: I think your company will grow slowly, but surely, especially because it has a really good lead. So, you had 15 years of experience working in corporate and 1 year of experience as an entrepreneur. Can you tell us how they’re both different or the same?


Ms. Palacharla: I would say, both are completely different. As a corporate employee, I worked on whichever projects the company assigned me. But here, at SafeVig, I have to take care of everything: from the beginning of the project until it gets assigned, and operations are complete. So, even if it is a small project, the feeling I have is really good and very satisfying. 


Pharma Now: Yes, managing entire projects is the most difficult and different part of shifting from a corporate employee to an entrepreneur. I heard your interview with Indigo’s ex-CEO, Aditya Pande, in which you explained how difficult it is to convert from a corporate employee to an entrepreneur. How was the transition for you? 


Ms. Palacharla: We have to be very strict with expenses because we have to run the show for a long period. If we spend more in the beginning, we can't sustain the business for long. One thing I will say: I got a lot of exposure as an entrepreneur, which I didn't get while working in the corporate world. That is the best thing I believe. 

Regarding the experiences I had in this 1 year, yes, there were some bad experiences initially because there were some rejections as we’re a startup. I spoke about this at the CEO Conclave to encourage startups. After 15 years of experience, we had a lot of aspirations and dedication; we wanted to do something for the world. 

But, in pharmacovigilance, where startups are not accepted by large pharma companies, it's very difficult for startups to sustain. That's why companies should encourage startups so that people like me, who want to start their business, can come out and do so very confidently. That's my thought process. 


Pharma Now: I agree, it's very difficult for startups to sustain in the initial few months or years. It is even more difficult in the pharmaceutical industry where there is so much competition. Other than expenses and competition, what other aspects are challenging for startups in pharma?


Ms. Palacharla: Their credibility has to be displayed because projects are given in their initial stages. So, companies have to show that they can sustain for a long period. “Are you going to survive?” That's the first question most people ask, but I think once they give us a chance, they can see us. 


Pharma Now: You want to make them realize that they were also a startup once.


Ms. Palacharla: Exactly. I want to tell people, “Companies that are big now were startups once.” I still remember the first project I signed with a pharma company. I asked the CEO, “Sir, what is your belief in giving us this project?” He said, “I want to encourage startups because my company was a startup once, and someone had encouraged me, that is why I'm in this position today.” 

So, he believed in me, and he gave me the project. 


Pharma Now: That's wonderful. So, now that you have a few projects under your belt and you manage your team, how’s your experience been in team handling? 


Ms. Palacharla: I have a very good team. They believed in me. They joined SafeVig. I consistently identify or recognize their work. I give them a lot of growth opportunities because, since SafeVig is a small company and a startup, we have many things and people can learn a lot. They need not restrict their knowledge only to pharmacovigilance–they can learn clinical operations, clinical data management, and everything they are exposed to, which will indeed help their career. That's how I give a lot of growth opportunities to my team. 

In case of any issues, any compliance issues, the best way of dealing with the team is by having a proper Corrective and Preventive Action (CAPA) management system. I'm very friendly with my team, which adds value. That's the reason the people in my team have been consistent for 1 year. 


Pharma Now: Wonderful. Now, SafeVig is one year old and you’re slowly building a growing team. What's your plan for SafeVig for the coming years?


Ms. Palacharla: Right now, we provide services, but we want to expand toward technology and product development. There are a lot of tools available in the market already that use artificial intelligence (AI) and machine learning (ML). But, we want to make the best cost-effective solutions that even small and mid-sized pharma companies can use and leverage. 


Pharma Now: AI has been integrated into many aspects of pharmaceutical manufacturing, and there are many more where AI has potential. Can you share how AI will impact pharmacovigilance?


Ms. Palacharla: 15 years ago, case processing used to take a lot of time. I remember we used to get case summaries of patients. I used to process them, and it took 7-10 days for a report because of how big the reports were. Now, AI and ML can be used to process these summaries within minutes. This is the difference. We get a lot of emails from patients, which can be tracked using automation. Automation of processes can reduce the time required and make the work scalable. 

The Food and Drug Administration (FDA) released a report which highlighted that adverse reporting has increased drastically. Hence, human resources are limited, so we have to utilize AI to process cases. Literature surveys are done in the same way. Pharma companies conduct a lot of literature surveys to make sure their product is safe. During this, they get thousands of hits. So, it is really difficult to process and track those cases. But using AI tools available in the market, this task can be completed promptly. So that is the difference or impact of AI on pharmacovigilance. 


Pharma Now: There’s a positive impact, but I’ve heard and read a lot of debate on the integration of AI, and one point that always comes up is: AI killing jobs. You said, that in pharmacovigilance a task that requires 7-10 days is completed within minutes by AI. So, is it fair to say AI is killing jobs?


Ms. Palacharla: That’s a tricky question. I always say one thing: We always have to upgrade. You always have to take a step out of your comfort zone. You have to learn new things like AI and ML. If you rely on traditional methods of case processing, the job is definitely at risk. But, you have to run with the world, and the world is running towards AI. So you have to match that pace now. People who are matching that pace will sustain. 


Pharma Now: I certainly agree with you. Rather than saying AI is killing jobs, we need to adopt AI to increase our productivity. This will have a greater impact on the industry and country.


Ms. Palacharla: As there are many AI tools available currently, the team can leverage these tools and reduce their working time. They can utilize this saved time to upskill themselves, which will help them. 


Pharma Now: Certainly, I agree with you. In startups, it always helps to upskill and integrate tools because they enhance the efficiency and productivity of the team. While I wish to continue, I think our time is up. It was wonderful talking to you and learning about SafeVig. I wish you the best. I appreciate your passion for the industry and your field. Thank you very much for joining Pharma Now and sharing your insights into pharmacovigilance. 


Ms. Palacharla: Thank you so much. 

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