面議(經常性薪資達4萬元或以上) 台北市信義區 3年工作經驗 今天剛更新
JOB DESCRIPTION
POSITION SUMMARY
He/she is responsible for managing, maintenance and continuous improvement of the PV system for Viatris in the affiliate and ensuring adherence to established local and Viatris Global PSRM policies and standards following national and international regulations/guidelines for pharmacovigilance.
POSITION RESPONSIBILITIES
ICSR handling:
Ensure that local processes, procedures and systems are in place for ICSR management.
Periodic Safety Reporting:
Inform global team about the requirement/ change in requirement of any PSUR in liaison with local regulatory affairs. Provide safety information required for preparation of periodic safety report.
Compliance:
Ensure a local tracking system is in place, to ensure timely submissions of ICSRs to global PV Operations.
Monitor Affiliate PV system performance and compliance.
Maintain awareness of local PV legislation and of relevant international legislations, regulations and guidelines.
Training:
Maintain a version-controlled training matrix for local PV personnel.
Ensure basic PV training of new Affiliate employees and refresher training at least annually and that appropriate training records are maintained.
Ensure training on and compliance to global and local SOPs, and relevant regulations.
SOPs:
Ensure implementation of PSRM standards and procedures, as applicable.
Ensure local processes and procedures are developed and implemented to define pharmacovigilance responsibilities in line with PSRM standards and procedures, as weIl as local regulations, as applicable.
Audits and Inspections:
Be the deputy key affiliate contact for both internal PV audits and regulatory authority PV inspections.
PV agreements:
Ensure a local process is in place for management of local PV agreements that conforms to Viatris Standards per global procedures and local requirements.
Risk Management Plan:
Ensure local implementation and tracking of activities in accordance with Risk Management Plans (RMPs)
Safety inquiries:
Ensures handling of inquiries relating to product safety including regulatory authority inquiries.
Safety Signals:
Inform global team bout any potential signal or safety concern identified at local level.
PV business continuity:
Ensure to planning of PV business continuity and notification of any business interruptions that pose a threat locally or globally to pharmacovigilance processes or endanger regulatory compliance.
Archiving:
Ensure record retention of all PV related data and documents according to Viatris Global requirements and national requirements.
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