Pharma 4.0, quality management, sorting pills into tray

5 ways Drug Safety can serve as a Business Accelerator

Drug safety departments are often seen as a cost center. This perception minimizes the value of drug safety operations and by repeating it, organizations are missing out on an abundance of opportunities for optimization and ultimately business acceleration. This article suggests ways that life sciences teams can gain added value and hopefully encourages a new perspective on drug safety and pharmacovigilance.

An important knowledge center that requires attention

Regulatory requirements are on the rise and ICSRs (Individual Case Safety Reports) are rising exponentially. The drug safety department has never been busier, and the case workflow is complicated by constant new regulations imposed.

The drug safety department is a knowledge center. It possesses information on the latest benefit risk ratio, real world evidence on the use and compliance of your products, contraindications, comorbidities, and much more.

This knowledge is currently being used with only health authority reporting and compliance in mind and is being locked away due to huge workloads and regulatory requirements, but it has much greater potential than that. Insights based on this knowledge should be shared across business units and sections in the pharmaceutical company, as these insights can optimize the work done across departments.

With moderate investments, it is possible to both optimize the tasks in the drug safety department, while leveraging the wealth of knowledge to be shared and utilized across the rest of the organization. The result is empowering the business to work smarter and stay efficient, even though the workload increases exponentially.

Where do we invest and how do we get started?

Investments in next generation pharmacovigilance tools often seem too large, however this does not need to be the case, as the tools are operational and adaptable by the company. Here are the 5 focus areas for you to start using drug safety as a business accelerator.

Understanding data standards and governance of data is the foundation of leveraging next generation safety tools

Data governance is the key enabler and most important starting point for transforming your pharmacovigilance function from a cost center to a value creation center

Organization-wide and third-party agreements on how data is shared across systems that streamlines complete oversight

Flexible integration governance structures support exchange of data across your organization and third-parties and are integral components of sustained compliance. They ensure continuous data consistency and help keep your resources focused on the essentials


With this flexible tool, lines of business can focus on important tasks and essential decisions

Functional Robotics Process Automation helps Pharmacovigilance experts with less switching between small tasks. It helps team members avoid decision fatigue throughout the workday. Robots complete the repetitive tasks so knowledge workers can focus on high value activities instead.

Powerful computing with predictive analysis and automation of important tasks

Artificial Intelligence (AI) can be very powerful if used correctly. Meaningful artificial intelligence supports critical human decisions earlier in the process. This enables teams to increase productivity, make better decisions, and react more quickly to changing requirements. It also requires high quality data to deliver high quality results.  You cannot have AI out of the box. You need to provide your data, uniform data and Quality data – as with a lot of other things the AI is built on what you feed it. In many ways AI is what it “eats”. Since it eats your data regardless of its condition, it is highly relevant for your business to feed it high quality data.

Cloud-based tools offer global access and ongoing flexibility

Cloud-based tools use natural language processing (NLP) and offer auto-generation of narratives and scalability

The investment in drug safety departments and tools will then give the following benefits:

  • Comprehensive oversight of the safety data lifecycle
  • Continuous compliance with agility to respond to emerging requirements such as IDMP
  • A single source of truth that is accessible by global teams
  • Efficient safety operations based on accurate process and data maps
  • Effective, data-driven communications and processes (compliance reports, ad hoc requests, product catalogue, and master data)
  • Increased productivity and global could-based access
  • Cloud based tools enable scalability and AI (e.g., auto narrative generation, smart predictions on case processing)
  • Meaningful tasks are focused, and trivial tasks are accelerated using e.g., RPA to do your trivial review of case processing tasks – leaving the SMEs to focus on decision making rather than copying & pasting data.


Do you want to learn more? Would you like guidance on where and how to start? Please feel free to reach out to me.