https://highondata.com/blogs/ Recent content in Blogs on High On Data Hugo -- gohugo.io en Wed, 11 Mar 2026 10:32:00 +0000 https://highondata.com/blogs/implement-xai-technique-for-transparency-explainability-data-privacy-in-pv/ Wed, 11 Mar 2026 10:32:00 +0000 https://highondata.com/blogs/implement-xai-technique-for-transparency-explainability-data-privacy-in-pv/ Artificial intelligence is rapidly modernising pharmacovigilance (PV). It now offers powerful capabilities for processing Individual Case Safety Reports (ICSRs), detecting safety signals, and predicting adverse drug reactions. However, as AI systems become more sophisticated, many rely on complex “black-box” models. These models can produce highly accurate results, but their internal reasoning is often difficult for humans to interpret. This raises an important question: How can PV professionals and regulators trust decisions they cannot clearly understand? https://highondata.com/blogs/ai-governance-compliance-risk-management-pharmacovigilance/ Tue, 03 Mar 2026 10:32:00 +0000 https://highondata.com/blogs/ai-governance-compliance-risk-management-pharmacovigilance/ Pharmacovigilance has long sat at the heart of patient safety, traditionally relying on structured processes and conservative risk management to detect and prevent adverse drug reactions. Today, Artificial Intelligence is fundamentally transforming PV operations-from automated case intake and triage using Natural Language Processing to machine learning algorithms identifying patterns across massive safety datasets. However, introducing dynamic, learning AI systems into a highly regulated environment raises a critical challenge: How do we govern and validate these systems while maintaining compliance and patient protection? https://highondata.com/blogs/vendor-oversight-sub-contracting-in-pv/ Fri, 02 Jan 2026 10:32:00 +0000 https://highondata.com/blogs/vendor-oversight-sub-contracting-in-pv/ Whether you are in a big pharma company, an emerging biotech, or a CRO, the reality is the same: we all rely on vendors. But simply hiring a vendor and hoping for the best doesn’t cut it anymore. Today, having a rock-solid oversight process and governance model isn’t just “nice to have” - it is survival. You might be asking, “Why the sudden urgency?” The short answer is that the regulators have drawn a line in the sand. https://highondata.com/blogs/what-worked-for-me-in-leadership-role/ Fri, 12 Dec 2025 10:32:00 +0000 https://highondata.com/blogs/what-worked-for-me-in-leadership-role/ For a significant part of my career, I thrived as an Individual Contributor. I had the opportunity to lead projects, make technical decisions, and managed project teams, but I eventually realized that managing a project is vastly different from leading people. Growing up, I was fortunate to be surrounded by exceptional leaders. Speaking with them didn’’’t just inform me; it inspired me. I aspired to be transformational, someone who motivates people to achieve both personal and organizational heights rather than a transactional manager who simply tracks tasks and manages output. https://highondata.com/blogs/validating-ai-system-in-pharmacovigilance-pv-fda/ Sun, 17 Aug 2025 10:32:00 +0000 https://highondata.com/blogs/validating-ai-system-in-pharmacovigilance-pv-fda/ In my previous post, I explored the European Commission guidelines and the EU AI Act, looking at how they influence AI applications and the validation strategies surrounding them. This time, I want to shift focus to the FDA’s draft guidance on AI, released in January 2025. Although still in draft form, the document is an important signal of how the FDA is approaching AI, and it helps us understand what kinds of validation methodologies are expected to align with global regulatory thinking. https://highondata.com/blogs/validating-ai-system-in-pharmacovigilance-pv-eu-ai-gmp/ Fri, 15 Aug 2025 10:32:00 +0000 https://highondata.com/blogs/validating-ai-system-in-pharmacovigilance-pv-eu-ai-gmp/ In my previous post, I explored how AI is transforming pharmacovigilance and highlighted use cases that go beyond case intake. Building on that discussion, I wanted to understand how organizations are validating AI applications and what regulatory guidelines say about it. While numerous frameworks exist-issued by bodies such as the FDA, WHO, CIOMS Working Groups, EMA, and Health Canada-I focused my review on two key documents: The EU AI Act EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines (draft) These are highly relevant to pharmacovigilance systems and encapsulate most of the critical points from other guidance documents. https://highondata.com/blogs/how-ai-is-shaking-up-pharmacovigilance/ Mon, 12 May 2025 10:32:00 +0000 https://highondata.com/blogs/how-ai-is-shaking-up-pharmacovigilance/ For the longest time, companies stayed away from trying out new tech stacks in pharmacovigilance (PV). But with the rise of generative AI, things are changing-fast. Big players like Bayer teamed up with Genpact to use AI for automating case intake. Sanofi joined hands with IQVIA to apply AI for end-to-end case processing. And these are just a couple of examples. As case volumes keep going up year after year, everyone’s now in a race to bring AI into the game-to cut costs, boost quality, speed up case processing, and let safety teams focus on what really matters. https://highondata.com/blogs/bottlenecks-in-pv-technology-companies/ Sat, 28 Dec 2024 10:32:00 +0000 https://highondata.com/blogs/bottlenecks-in-pv-technology-companies/ A few months ago, I had an insightful conversation with a PV leader who asked about the current opportunities within PV technology for a CRO. Like most, my initial response was a generic suggestion—embrace AI, automate processes, and so on. However, this post isn’t about the usual recommendations you hear everywhere. Now that I’ve spent considerable time in the pharmacovigilance domain, I’ve encountered specific bottlenecks that persist in PV technology companies. https://highondata.com/blogs/product-management-interview-questions/ Fri, 23 Aug 2024 10:32:00 +0000 https://highondata.com/blogs/product-management-interview-questions/ Over the past year, I’ve had the opportunity to interview for several senior Product Manager roles. After going through multiple interviews, I noticed a pattern in the questions being asked, and I thought it would be helpful to share them here on my blog for those preparing for similar positions. The questions I encountered typically fell into four main categories: Categories of Interview Questions By sharing these insights, I hope to provide a useful resource for fellow product managers looking to advance their careers. https://highondata.com/blogs/data-visualization-basics-for-product-manager/ Thu, 28 Mar 2024 12:00:00 +0000 https://highondata.com/blogs/data-visualization-basics-for-product-manager/ Data Visualization Basics for Product Managers As a product manager, you’re constantly swimming in a sea of data. Whether it’s metrics on product performance, website traffic, customer data, or market insights, understanding and making sense of this data is crucial for informed decision-making. Today, let’s dive into the basics of data visualization and how it can empower you in your role. Getting Started with Data Before diving into visualization, it’s essential to get acquainted with your data. https://highondata.com/blogs/factor_analysis_using_principal_component_method_spss/ Sun, 01 Oct 2023 10:32:00 +0000 https://highondata.com/blogs/factor_analysis_using_principal_component_method_spss/ Factor analysis is a statistical method that can be used to reduce many variables into a smaller number of factors that explain the underlying structure of the data. Principal components analysis (PCA) is a type of factor analysis that is commonly used in practice. PCA works by transforming the original variables into a new set of variables called principal components. The principal components are ordered by their eigenvalues, with the first principal component explaining the most variance in the data, followed by the second principal component, and so on. https://highondata.com/blogs/mastering_the_art_of_guestimation_essential_skill_for_pm/ Sun, 10 Sep 2023 01:00:00 +0000 https://highondata.com/blogs/mastering_the_art_of_guestimation_essential_skill_for_pm/ In the fast-paced world of product development, where time is of the essence, decision-makers often find themselves in situations that demand quick yet informed choices. This is where the art of guestimation comes into play, offering a valuable tool for Product Managers (PMs) to make rapid assessments and drive innovation. My strategy professor used to call it Back of tissue analysis . In this blog post, we’ll explore guestimation and how it can help PMs in new product development or feature enhancements. https://highondata.com/blogs/conjoint_analysis_using_excel_for_build_a_better_product/ Fri, 08 Sep 2023 11:30:00 +0000 https://highondata.com/blogs/conjoint_analysis_using_excel_for_build_a_better_product/ As a product manager of a SaaS company that is planning to create a new cloud storage app, you know that there are already a few great options available on the market. So how can you make sure that your app stands out from the crowd? One way is to use conjoint analysis. Conjoint analysis is a market research technique that can help you understand how customers value the different attributes of a product or service. https://highondata.com/blogs/data_analysis_of_netflix_subscribers_revenue_library_stock_price/ Fri, 04 Aug 2023 11:30:00 +0000 https://highondata.com/blogs/data_analysis_of_netflix_subscribers_revenue_library_stock_price/ Following a record year that saw Netflix add 36 million subscribers in 2020, the world’s most popular video streaming service saw its subscriber growth slow significantly last year. According to the company’s earnings release, Netflix added 8.3 million subscribers in the last three months of 2021, bringing total subscriber growth for the year to 18.2 million. That’s the lowest annual subscriber gain since 2016, when Netflix added roughly the same number of new subscribers. https://highondata.com/blogs/the-cheat-code-to-learn-anything-using-feynman-technique/ Sun, 18 Jun 2023 10:32:00 +0000 https://highondata.com/blogs/the-cheat-code-to-learn-anything-using-feynman-technique/ 📌TL;DR: Feynman technique is a 4 step learning method that involves explaining a topic in your own words as if teaching a child. It helps you to understand & recall complex topics and simplify ideas. What one fool can understand, another can.” – Richard Feynman Richard Feynman was a Nobel Prize-winning physicist and one of the most remarkable scientists in history. He was a renowned lecturer who taught at Cornell and Caltech.