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 4天前更新
Overall Objectives
Safety Officer, under the leadership of Lotus PVO (Pharmacovigilance Operations) Head, is responsible for execution of PVO activities in accordance with the Lotus pharmacovigilance quality system and local pharmacovigilance requirements.
General Duties
• Participates in or conduct daily PVO activities assigned by PVO Head
• Maintains an accurate and comprehensive list of the Lotus products which are subject to pharmacovigilance activities by monthly alignment with the Regulatory Affairs teams
• Coordinates with Local PV Offices (LPOs), PV CROs and partners or vendors regularly for PV activities
• Monitors and tracks the PV activities performed by the stakeholders/LPOs, including, but not limited to:
• Screening of local legislation and regulatory safety announcements, screening of local scientific journals for relevant safety information, as required
• Maintenance of PV trackers (Individual Case Reports, Medical Inquiry and Product Quality Complaint, Aggregate Report tracker, Risk Management tracker, Safety Data Exchange Agreement tracker)
• Updating of PSMF (Pharmacovigilance system master file) and relevant annexes as required
• Reviews Individual Case Safety Reports (ICSR) and Medical Inquiries (MIs), as needed
• Is aware of the risk management plans approved in their territory and of the risk minimization measures implemented. Assists in ensuring that the required activities are performed and tracked
• Assist with the preparation and review of aggregate safety update report (PSUR, PBRER etc.)
• Is aware of local safety concerns and supports the signal detection activities by reviewing the outcome of the screening of the local PV legislation and safety announcement, as required
• Maintains and files the PV documents filed in the PVO specific folders (hard copy, where required and soft copy)
• Coordinates for translation of PV related documents, when required
• Tracks received adverse event, MI and PQC. Participates in reconciliation of PV activities between the Local PV Offices (LPOs) and PV CROs or partners or verifies that reconciliation activities are performed as per requirement
• Supports in submission of relevant ICSRs received to competent authority within deadline
• Participates in regular meetings with PVO and PV CRO as required and in-charge of MOM
• Consults PVO Head for any issues or uncertainties relating to pharmacovigilance activities
• Communicates with LPOs, PV CRO and other external PV vendors
• Informs PVO when contacted regarding agreement involving pharmacovigilance obligations
• Supports during audits and inspections
• Trains on and applies the Lotus pharmacovigilance SOPs and the applicable PV related regulation
• Stays current on the local PV legislation in the Lotus MA countries
• Is involved during the development of Lotus pharmacovigilance SOPs
• Ensures that all relevant employees in the LPOs receive basic pharmacovigilance training and that training is recorded and archived appropriately
• Performs any other PV related activities assigned by the line manager (PVO Head)
• Liaise with the stakeholder department or other internal departments.
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