Safety and Pharmacovigilance: Department Models and Structures

Report Overview

Industry Standard Research interviewed experienced safety and pharmacovigilance decision-makers to get a better grasp on the function. These professionals shared their perspectives on topics such as the role of safety and PV within their organizations, how their departments are structured, how the function interacts with other departments within their companies, and key challenges faced by safety and PV employees. ISR also collected insights on department headcounts, outsourcing practices, and department funding.

ISR conducted 11 in-depth interviews with tenured post-marketing safety and pharmacovigilance professionals from leading biotechnology and pharmaceutical companies in North America and Europe.

How you can use this report:

• Determine where your company’s approach to safety and pharmacovigilance may be different from a typical industry approach and the benefits and drawbacks that may result.
• Gather information on safety and pharmacovigilance structures and philosophies employed by other organizations to provide a new perspective from which to consider your company’s philosophies.
• Compare the size of your company’s safety and pharmacovigilance function to that of other companies.

Major Topics:

• Safety & PV Goals
• Safety & PV Employees
• PV Work Throughout Development
• Department Size & Structure
• Organizational Alignment
• Effectiveness Measures
• Budgets & Funding
• Outsourcing
• Challenges
• Future Predictions
• Best Practices & Recommendations