Responsibilities
- Develop and sustain Pharmacovigilance System Master Files according to international regulations, client-specific mandates, and internal standards
- Oversee and administer client PSMFs throughout their lifecycle
- Draft PSMF documentation
- Perform updates and revisions of PSMF content
- Conduct quality assurance reviews of PSMF documents
- Monitor and manage version control and tracking of PSMFs
- Participate in recurring PSMF coordination meetings with internal teams and client representatives
- Support regulatory audits or inspections related to PSMF functions when required
- Revise and maintain quality-related documentation associated with PSMF processes
