The Impact of Organizational Change Management in Selecting a Pharmacovigilance System

Selecting a New Pharmacovigilance System

Selecting a new pharmacovigilance system is a big decision that the company will have to live with for many years into the future. At Astrix, we advise our clients and assist in leading the process of selecting a new system which also involves organizational change management. A critical aspect to any change like this is to ensure that there is a strong alignment with the leadership team and everyone involved in the selection process. That cohesion is imperative.

Leadership needs to follow these best practices:

  • Develop clearly defined objectives for the system selection.
  • Understand the key stakeholders and be visible from the beginning, conveying a sense of urgency along with the business rationale for why this new system change is needed.
  • Develop consistent messaging that is tailored to specific stakeholders (or stakeholder groups) so they understand why this change is not only important to the business but also important to them.
  • Provide regular reinforcement around the tenets and reasons for change throughout its implementation

There also needs to be an alignment on measurable goals related to the objective of the selection and implementation of this new system.

Moreover, having the right people involved in the selection process is also critical. Typically, you should look for change agents, early adopters, and organizational influencers to actively participate in the project. This is particularly important during the Definition & Engagement phase of the project as this team will set the direction and lay the foundation for the overall project.

Identify the right team for the project, who have:

  • Authority to make decisions around the planned selection process.
  • Insight into the overall workflow that will be affected as well as the larger impacts organizationally.
  • Credibility and respect of the organization, from the bench to the leadership team.

Additionally, Key stakeholders, both internal and external to the organization, must be identified early in the program. To ensure success in the system selection process these best practices should be utilized:

  • Clearly defining roles and responsibilities related to the system selection.
  • Ensure organization-wide understanding which will be supported by the alignment and metrics.
  • Ensure everyone understands their accountability for their new responsibilities within the system selection process.

Finally, it is important to ensure excellent communications across the team involved in this project. Regular meetings leveraging the best channel is necessary whether that is a phone meeting or a video conference. This will ensure everyone is on the same page.


The system selection process is not easy. There are many considerations beyond the organizational change management aspect we have outlined. The key to success is to ensure you leverage both your internal and external resources to facilitate an effective and efficient process to evaluate and select the optimal solution for your business.

Each organization is different, and the people involved in the project are critical. Everyone involved needs to understand the objectives and their role and responsibilities. Effective communication and alignment of the organization on a common objective is imperative. Utilizing the right people both internally and from a consulting perspective will help to ensure success.

Why It Matters To You

They say the only constant in business is change. Any organization that is looking to select a new Pharmacovigilance system needs to understand the organizational impact. From the leadership down, everyone needs to understand why this new system is an imperative and their roles and responsibilities.

In this pharmacovigilance focused blog we discussed:

  • The value of ensuring understanding and alignment of everyone towards a common goal in the system section process.
  • The key considerations regarding organizational change that impact the pharmacovigilance system selection process.
  • Who needs to be involved in the process and why?

To learn more about this topic, download our whitepaper on the Six Key Considerations When Selecting a Safety System

About Astrix

For over 25 years, Astrix has been a market-leader in delivering innovative solutions through world class people, process, and technology that fundamentally improves scientific outcomes and quality of life everywhere. Founded by scientists to solve the unique challenges life sciences and other science-based business face, Astrix offers a growing array of strategic, technical, and staffing services designed to deliver value to clients across their organizations. If you would like to explore how to optimize your Pharmacovigilance area, please contact us.