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Expertise

Dr. Vivek Ahuja

Senior Vice President, Compliance Services

Expertise:

Clinical Research, Compliance, Pharmacovigilance, Regulatory Compliance

Dr. Vivek Ahuja serves as EVERSANA’s Senior Vice President for Delivery Excellence, Strategy, and Growth (PV, Quality, and Regulatory Services) with over 22 years of experience across multiple functional offerings including Pharmacovigilance, Clinical Research, Technology, and Public Health. A physician by education (MD) with training in business administration (MBA) and a seasoned professional in the pharmaceutical industry, Dr. Vivek Ahuja pioneered the introduction of pharmacovigilance as a subject and science in India in the year 2003. Having been in a global role for the past 17 years of his career, he has experience in working in worldwide pharmacovigilance regulations related to drugs, vaccines and devices.

Prior to joining EVERSANA, Dr. Vivek Ahuja was Vice President for Medico-Regulatory Affairs, Clinical Data Research and Global Head of Pharmacovigilance at Sun Pharma, the 4th largest global generics company and the largest of its kind in India. With his vision he established the country’s first global pharmacovigilance unit in the country’s largest pharmaceutical company and scaled up several such organizations in this field. He has been actively involved in policymaking efforts for many years in the region, including co-authoring the National Pharmacovigilance Program of India in 2010 and supported the Nepal and Bangladesh governments in developing focused pharmacovigilance programs for neglected drugs.

Vivek is passionate about the applications of AI, ML and NLP and wants to make a significant difference to the business using these capabilities.

Articles by Dr. Vivek Ahuja

The Art of Simplifying Pharmacovigilance – Part V: Deconstructing Automation

The use of automation continues to be on the rise, and that trajectory is not slowing down anytime soon, if ever. In relation to pharmacovigilance, automation’s ascent and how it is impacting the industry is especially significant. This creates multiple critical decisions for manufacturers to consider sooner rather than later. So, where to begin? If you ask these three vital questions, you will have a fair idea: Are you fully harnessing the potential of your current safety database application to the fullest? What is the volume of cases you process in each of the case types you receive? What is the break-even point for you if you invest in newer […]

The Art of Simplifying Pharmacovigilance – Part IV: Streamlining Vendor Engagement for Marketing Authorization Holders

It is often overlooked how many vendors a Marketing Authorization Holder (MAH) engages with. The more you spread your resources, the more scattered your focus becomes. Conversely, the more you concentrate your efforts, the more you gather and achieve. Managing everything together becomes a nightmare for MAHs. Imagine a hospital diverting its attention from its core competence and attempting to manage peripheral services like pharmacy chains, hospitality services, laundry, food provision, laboratory services, machine maintenance, and account management. By doing so, they would lose sight of their primary purpose: providing expert care to save lives. Similarly, an MAH can quickly lose sight of its primary responsibility, which is to review […]

The Art of Simplifying Pharmacovigilance – Part III: Unlocking Efficiency Through Consolidation

Just a few years ago, accessing entertainment on television was simple. However, the emergence of Over The Top applications for streaming content has made it complex, requiring users to manage multiple accounts and subscriptions. Consequently, users find themselves spending more than they ever intended due to the lack of a comprehensive grasp on their total streaming expenses. A similar challenge exists in the realm of pharmacovigilance outsourcing. On average, a manufacturer doing business in several countries engages with seven vendors for Pharmacovigilance services. For example, a manufacturer’s vendor for hosting the safety database may be different from the one responsible for maintaining and updating the database, and they may both […]

The Art of Simplifying Pharmacovigilance – Part II: Change Adoption

Considerable effort is dedicated to inputting clean adverse event data into a safety database, even before conducting the analysis to extract insights. In this scenario, manufacturers are investing more resources in the process of inputting data from various sources than analyzing and researching the information. To right-size where the primary focus is, manufacturers must adopt a high-tech high-touch approach to pharmacovigilance that blends automation and human interaction. Fear frequently stands as the primary barrier linked with change, arising from an inadequate comprehension of a process and a reluctance towards the unknown and its associated risks. However, if there is an opportunity to enhance efficiency, improve quality and adapt to evolving […]

The Art of Simplifying Pharmacovigilance – Part I: Connecting the Dots

The Art of Simplifying Pharmacovigilance – Part I: Connecting the Dots In the intricate realm of pharmacovigilance, there is an art — a delicate dance of connecting the dots. Like a skilled painter, vigilant professionals adeptly simplify the complex web of drug safety, linking scattered points to reveal a cohesive picture. With unwavering focus, they navigate vast databases and countless reports, tirelessly seeking patterns, correlations, and signals. Each connection brings a clearer understanding, empowering them to safeguard the health and well-being of countless individuals. It is a symphony of vigilance, where data harmonizes with expertise. The art of simplifying pharmacovigilance is a masterful tapestry of insight and diligence, painting a […]

Artificial Intelligence and Machine Learning Use in Patient Safety

The next several decades will bring increased use and advancement of technology, particularly with regard to Artificial Intelligence (AI) and Machine Learning (ML) within our personal lives and in the pharmaceutical industry.   Generally, the ways in which AI and ML are leveraged will determine the maximum outcomes and impacts. However, challenges are present. For example, in natural language processing lexical ambiguity and syntactic ambiguity present dangerous obstacles the technology cannot. As many ponder where AI and ML will replace jobs, it is capabilities gaps such as this that remind us why human involvement remains so crucial.  Though powerful and certainly efficient, automation will not always be the answer due […]

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