Responsibilities
- Create and maintain Pharmacovigilance System Master Files according to international regulations, client standards, and internal policies.
- Manage and oversee the ongoing maintenance of client PSMFs.
- Draft sections of PSMF documentation as required.
- Revise existing PSMF content to ensure regulatory and operational accuracy.
- Conduct quality reviews and checks on PSMF materials prior to finalization.
- Monitor and log changes, updates, and version history of PSMF documents.
- Participate in scheduled meetings with internal teams and clients regarding PSMF status and deliverables.
- Support audit and inspection activities when relevant to PSMF processes and documentation.
- Update and maintain quality-related documents associated with the PSMF.
