Pharma 4.0, quality management, sorting pills into tray

3 ways Drug Safety can serve as a Business Accelerator

- Ingelise Bærentzen Melchiorsen, Head of Drug Safety, NNIT

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.

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. We suggest 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

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.

- When PV and Drug Safety continues to be seen as a cost center, it minimizes the value of the department and the opportunities for optimization and business acceleration, says Ingelise Bærentzen Melchiorsen, Head of Drug Safety at NNIT.

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.

- The drug safety department is not just a crucial knowledge center, but also a catalyst for positive change. By harnessing the power of shared information across organizations, we have the potential to empower drug safety organizations and drive significant improvements in business outcomes. In industries where the quality of life is at play, our collective efforts can make a profound difference in ensuring the safety and well-being of patients worldwide, says Ingelise Bærentzen Melchiorsen.

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 3 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, as it enables organization-wide and third-party agreements on how data is shared across systems, thereby streamlining complete oversight

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, as flexible integration governance structures support the exchange of data across your organization and third parties, and serve as integral components of sustained compliance, ensuring continuous data consistency and keeping your resources focused on the essentials.

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With this flexible tool, powerful computing enables lines of business to focus on important tasks and essential decisions, utilizing predictive analysis and automation to streamline critical operations

Functional Robotics Process Automation helps Pharmacovigilance experts by reducing the need for switching between small tasks, thus alleviating decision fatigue throughout the workday. Robots take care of repetitive tasks, allowing knowledge workers to focus on high-value activities. Furthermore, when used appropriately, meaningful artificial intelligence (AI) can be a powerful tool. It supports critical human decisions early in the process, enhancing productivity, decision-making, and responsiveness to changing requirements. However, AI's effectiveness relies on high-quality data, as it is built upon and influenced by the data it consumes. To maximize AI's potential, businesses must provide uniform and quality data, recognizing that AI's performance is strongly linked to the quality of the data it "eats."

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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.

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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?

Unlock deeper insights and recognize greater value from your safety data processes by modernizing your pharmacovigilance capabilities.

Would you like guidance on where and how to start? Please feel free to contact us for more information on how we can help you improve drug safety end to end.