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    • 彰濱廠-儀電助工師
      台灣玻璃工業股份有限公司
      彰化縣鹿港鎮
      1. 負責更換、調整及修理電氣/電子設備的故障零件。 2. 維持工廠內電氣/自動化系統之正常運作。 3. 測量儀器與校正。 4. 完成主管交辦事宜。 5. 須配合輪班，另加給輪班津貼(約6000~7000元，以實際天數計算)。
      台灣玻璃工業股份有限公司 位於 台北市松山區南京東路三段261號11樓
      彰化縣鹿港鎮
    • 藥物安全監視人才 Safety Officer, Pharmacovigilance Operations (PVO)
      美時化學製藥股份有限公司
      台北市信義區
      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.
      美時化學製藥股份有限公司 位於 南投縣南投市成功一路30號(南投工業區)
      台北市信義區
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