Manager

• Manage activities of CROs, vendors, and temporary staff performing PV operations.
• Oversee and guide case processing activities to ensure effective monitoring and evaluation of product safety information.
• Oversee PV system to ensure compliance of employees, partners and distributors.
• Maintain safety databases (e.g., Argus, ArisG) and ensure data accuracy and compliance.
• Ensure ongoing maintenance and revision of PSPV Standard Operating Procedures, Work Instructions, and Job Aids.
• Ensure PV operation continuity including maintenance of process or disaster recovery plan of Safety Database.
• Supervise and manage preparation and submission of aggregate reporting in accordance with applicable regulations.
• Maintain training matrix in PSPV team and lead trainings of PSPV members or new hires.
• Oversee preparation and execution of deviation reports, note to files and Corrective and Preventive Actions (CAPAs).
• Manage pharmacovigilance agreements or safety clause in contracts with partners or CROs.
• Act as the responsible contact person for safety-related aspects and PV.

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