Responsibilities
- Create and maintain Pharmacovigilance System Master Files according to international regulations, applicable laws, and client-specific requirements.
- Manage and maintain client PSMFs throughout their lifecycle.
- Author Pharmacovigilance System Master Files from inception to completion.
- Revise existing PSMF content to ensure ongoing compliance and accuracy.
- Conduct quality checks and reviews of PSMF documentation.
- Track changes, versions, and approvals related to PSMF documents.
- Participate in scheduled meetings with internal teams and clients regarding PSMF activities.
- Support audit and inspection processes when responsibilities fall within the PSMF scope.
- Update and revise quality-related documents associated with the PSMF.
