美時化學製藥股份有限公司
藥物安全監視人才 Safety Officer, Pharmacovigilance Operations (PVO)
9/18 Updated
Array
Full-time
Senior Level
Salary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
台北市信義區
Required
Work Experience
3年以上
Job Description
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.
Number of Openings
1~1人
Educational Requirements
大學(學院)以上
Field of Study Requirements
醫學系相關、藥學相關
Work Schedule
日班
Leave Policy
依公司規定
Job Category
Other Medical Staff
Other Health Professionals
南投縣南投市
藥品製造業
美時化學製藥成立於 1966 年，是一個立足台灣、放眼國際的學名藥廠，目前為台灣營收規模最大的製藥公司，專注生產口服癌症用藥並銷售全世界。
美時以亞洲地區最頂尖的研發中心與生產設備，也是台灣唯一同時獲得美國 FDA、歐盟 EMA、日本 PMDA、中國 FDA 及巴西 ANVISA 認證的藥廠，全力以高品質、高近用性的藥物滿足未竟的醫藥需求，改善人類生活品質，致力為病患、員工與所有利害關係人創造最大利益。
透過目前足跡廣布台灣、韓國、泰國、越南、新加坡、香港、馬來西亞、菲律賓、與中國的直營市場，以及與一線藥廠成為合作夥伴，美時的高價值產品得以銷售至世界各角落，是少數能進軍所有國際市場的台灣藥廠。
