Pharmacovigilance Training Guidelines

1) Purpose

The purpose of this SOP is to define the process for developing, implementing, and maintaining a comprehensive pharmacovigilance training program to ensure all relevant staff are knowledgeable about pharmacovigilance requirements and practices.

2) Scope

This SOP applies to all personnel involved in pharmacovigilance activities and those requiring training on pharmacovigilance processes and regulations.

3) Responsibilities

The Training Coordinator is responsible for the development and execution of the training program. All staff are responsible for completing required training and applying the knowledge in their roles.

4) Procedure

4.1 Training Needs Assessment

1. Identify the training needs based on job roles, responsibilities, and regulatory requirements.
2. Conduct a gap analysis to determine the existing knowledge and skills versus the required competencies.

4.2 Development of Training Materials

1. Create training materials that cover the required pharmacovigilance topics, including regulations, guidelines, and internal procedures.
2. Ensure training materials are up-to-date and reflect the latest regulatory requirements and industry best practices.
3. Incorporate various training methods, such as workshops, e-learning modules, and hands-on sessions.

4.3 Implementation of Training Program

1. Schedule and conduct training sessions for all relevant staff.
2. Ensure new employees receive initial pharmacovigilance training as part of their onboarding process.
3. Provide ongoing training and refresher courses to keep staff updated on any changes in regulations or internal procedures.

4.4 Evaluation of Training Effectiveness

1. Assess the effectiveness of the training program through quizzes, assessments, and feedback surveys.
2. Analyze the results of assessments to identify areas where further training may be needed.
3. Make necessary adjustments to the training program based on evaluation outcomes and feedback.

4.5 Documentation and Record Keeping

1. Maintain accurate records of all training activities, including attendance, training materials, and assessment results.
2. Ensure training records are securely stored and easily accessible for audits and inspections.
3. Update training records promptly to reflect completed training sessions and certifications.

5) Abbreviations, if any

PV – Pharmacovigilance

6) Documents, if any

Training needs assessment forms, training materials, attendance records, assessment results, feedback surveys.

7) Reference, if any

EU Good Pharmacovigilance Practices (GVP) Module I, ICH E2E Pharmacovigilance Planning.

8) SOP Version

Version 1.0