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Making Pharmacovigilance a Company-Wide Responsibility
Posted on June 20th, 2016 by Christy J. Wilson in Pharmacovigilance
The scope of pharmacovigilance has expanded. Regulatory agencies have placed new demands on how pharmaceutical companies are expected to ensure the safety of their products and manage benefit–risk. The pharmacovigilance departments alone cannot meet the new requirements. How best to make pharmacovigilance a company-wide responsibility?
It’s always tempting to consider a given task the sole responsibility of a given department. It is after all the traditional corporate structure. However, the new regulations don’t just require oversight of case processing, signal management and risk management, all of which sit primarily within the defined role of a pharmacovigilance department.
For example, pharmacovigilance procedures are now expected to include oversight of information such as product licensing, out of stock situations and the timeliness of submitting safety-related variations for product packs to the authorities. Some of these tasks might involve two departments, but some might require input from many more—and even from vendors.
Pharmacovigilance leaders and other senior company managers need to work together to ensure that the company as a whole is ready for the new situation. There are three fundamental steps to be taken:
- Gaining an understanding of the scope and risks within the current system to address problems that might expose the company to audits, fines and lawsuits
- Starting organization-wide education and alignment programs
- Creating a system that can be proactively updated and maintained in the future
To create such a system, there are three key considerations that will help drive efficient and effective processes and ensure end-to-end pharmacovigilance.
- Understanding the main handoffs from department to department and internal to external entities within the system
- Identifying areas where efficiencies can be improved and refining the system
- Implementing changes and communicating the rationale behind them clearly
Pharmacovigilance activities have to cover the whole lifecycle of medicinal products in relation to safety. All the involved parts of the organization have to remain in communication if the risk to the company is to be properly mitigated. It is certainly a challenging time to be a pharmacovigilance leader, but with the right strategy and vision, as well as support from other departments, even this increasingly complex era of regulations can be navigated.
Interested in a more detailed look at this topic? This white paper covers the key considerations for today’s pharmacovigilance leader when it comes to ensuring patient safety and regulatory compliance in the face of expanding requirements.
All opinions shared in this post are the author’s own.
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Christy J. Wilson
Sr. Director, Pharma and Biotech Segment
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