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How can large-scale patient safety operations prepare for digital transformation?

2 Nov 2022

Adverse events are a critical part of pharmacovigilance (PV), as it helps in identifying and tracking potential safety and data integrity issues with medications. As per FDA AE Reporting System (FAERS) Dashboard, AEs reporting 1 has increased at a CAGR of 10% from 2012 to 2021. This significant growth rate can be attributed to the introduction of newer therapies, increased patient interactions, evolving regulations, and increased sources of AE reports, including social media 2, 3 and mobile medical applications 4, 5 . Life science organizations have been actively pursuing innovative technologies to manage increasing volumes of safety-related data from new and disparate sources. But organizations have been conservative regarding taking the plunge toward large-scale implementations.

At the Indegene Digital Summit 2022, industry experts from Pfizer, GSK, J&J, and Sanofi shared their insights on how life sciences organizations can couple enterprise-wide transformation with organizational readiness while seeking to maintain or improve quality and compliance. They also talked about digital initiatives they have undertaken to scale their pharmacovigilance operations during expanding portfolios and increasing volumes. The key highlights from the discussion are summarized below.

What does a transformation in PV look like?

PV presents a unique opportunity to find efficiency, given the amount of manual, highly intensive, and repetitive human effort. A transformation in PV would mean:

Automating processes to improve consistency and reliability

“Besides efficiency, PV transformation should aim for automation to achieve consistency as it translates to quality. An excellent physician could look at a case on Monday and the same one on Friday and might come up with different results. And one of the things that AI can do is organize the information and do it consistently. Consistent decisions!” says Stephen Kuske, VP, Global Head of PV Operations at Sanofi.

Leveraging valuable data and generating actionable insights to support decision making

Another objective would be to leverage valuable data from a content standpoint. Priyank Agarwal, IT Director - Head of IT Global Medical Safety at J&J, explains that digital transformation in PV must support better decision-making- “Key to the future is the human plus machine model; a skilled team will use an engaged AI to amplify their capabilities”

But it is not enough to crystallize aspirations of PV transformation into the objectives of digital transformation. One needs to drive outcomes!

“The essential thing in the current world is how quickly we can get actionable insights that can prove the effectiveness of new therapies and keep our patients and consumers safe” - Priyank Agarwal, IT Director - Head of IT Global Medical Safety, Johnson & Johnson

What does it take to realize the transformation aspirations in this people and process driven function of PV?

Build your network of change agents and change champions:

The leadership must bring people together with a mission and purpose-driven action plan. A clear roadmap must be established to explain how the changes can help people in their day-to-day roles fulfill their long-term career path. Change management requires individuals who can bridge the gap between the implementation of a new program and the corresponding learning and development that goes with it.

"A good change initiative starts with having the right human-tech ratio" - Michael Glaser, Safety Innovation Technology Director. GSK

Understand the processes before re-inventing them:

“What does the existing process look like? What are the problems in the process and what can be done to solve them? How can we re-envision it? Organizations need to carefully consider these things before jumping on the next shiny object that comes their way. Michael Glaser, Safety Innovation Technology Director at GSK advocated on the need to focus on the problem before getting into a solution mode. Start with “why does the problem exist” before jumping to “how do we solve it.”

Establish clear expectations and the end goal:

Start with a great vision and break that down into smaller and achievable blocks. Follow up with critical questions - What can we accomplish? What is feasible today? It is all about trade-offs! Not everything needs to be accomplished in one go. Identify the component of the grand vision that can be accomplished today with resources at your disposal. And one must look beyond cost-savings as the ultimate benefit—cost avoidance, quality improvement, and better patient service.

“Have a big dream or vision but break that into smaller and achievable blocks” - Stephen Kuske, VP, Global Head of Pharmacovigilance Operations, Sanofi

How to navigate through a digital transformation in PV while maintaining or improving quality and compliance?

There are always new products and new data channels coming in. So, the number of AE reports will keep surging. And when you start introducing technology in the PV function, it becomes a big concern to maintain compliance as it is directly related to patient safety. How can organizations navigate through a transformation?

Quality Plan: Geo Pajovich, Vice President, Head of PSSR at Pfizer, put forward the concept of quality plans to ensure compliance. One can follow a quality plan which is supported by timeliness and quality metrics. If metrics drop below the thresholds, action can be taken in form of reporting the incidence as a quality event or following up to maintain compliance.

Upskilling and Cross-skilling: “You need to change what people do in the system. One must enable people to build different skills, particularly in data analytics and visualization,” says Stephen Kuske. For example, case management needs lots of people to process individual cases. But you still need people even after introducing technology such as AI. You need to maximize what the AI does if you manage a lot of structured data. And for this, you need people with different skill sets that will help you optimize and ensure that the structured data is right and loaded into the system. It would help to have more people managing that system process and fewer people doing the traditional work in that system. While offsetting in one area, you will have to build up another area.

“Have a good quality plan with established metrics and thresholds. Have a plan and know what you will do if things drop below a point and then you can defend your new process” - Geo Pajovich, VP, Head of PSSR Pfizer

Overall, this panel discussion is filled with examples from the day-to-day practices of industry PV experts and key drivers that can facilitate the transformation in large-scale safety operations while maintaining or improving quality and compliance. This can help in identifying potential areas of PV deserving transformation and how digital initiatives are creating an impact.


  1. FAERS public data base- AE reports from 2012 to 2021
  2. Yang M, Kiang M, Shang W. Filtering big data from social media—Building an early warning system for adverse drug reactions. J Biomed Inform. 2015;54:230-40
  3. Freifeld CC, Brownstein JS, Menone CM, et al. Digital drug safety surveillance: monitoring pharmaceutical products in Twitter. Drug Saf. 2014;37(5):343-50
  4. Iqbal E, Mallah R, Jackson RG, et al. Identification of adverse drug events from free text electronic patient records and information in a large mental health case register. PLoS One. 2015;10(8):e0134208
  5. Haerian K, Varn D, Vaidya S, Ena L, Chase HS, Friedman C. Detection of pharmacovigilance-related adverse events using electronic health records and automated methods. Clin Pharmacol Ther. 2012;92(2):228-34