台灣雙健維康生技顧問有限公司
Medical Writing Specialist/ Pharmacovigilance Specialist
9/18 Updated
Array
English Required
Full-time
Mid to Senior Level
English RequiredSalary & Location
Salary negotiable
(Regular monthly salary of NT$40,000 or above)
台北市大安區
Required
Language Requirements
English
聽/精通、說/精通、讀/精通、寫/精通
Work Experience
1年以上
Job Description
This position has 2 roles:
1. Medical Writing (MW) Specialist is responsible for the following tasks:
• Conduct literature/regulation/guidance search.
• Organize and archive study files and documents.
• Manage task schedule tracking and reminding.
• Perform format check of documents.
• Prepare presentation materials.
• Prepare revision summary between document versions.
• Assist the preparation of US FDA IND package.
• Apply payment for various use (e.g. transporation and copying).
• Acquire license of questionnaires and scales for the study use.
• Perform preliminary medical coding and preliminary manual check of data validation.
• Assist the pharmacovigilance activities if assigned.
• Compose meeting minutes.
• Arrange any first-step document preparation. May involve in document writing if deligated from the Medical Writer or under the supervision of Medical Writer.
• Complete other tasks assigned by the Head of Medical Writing Department.
2. Pharmacovigilance (PV) Specialist is responsible for the following tasks:
• Review of AEs/SAEs from clinical trials; issue and address queries if necessary.
• Perform medical coding for adverse events and concomitant medication.
• Be the representative and point of contact for safety receiving from clinical sites and reporting to the health authority.
• Author SAE narrative and individual case safety reports (ICSR).
• Participate in the development of safety-related data collection forms for clinical studies.
• Develop and review safety management plans.
• Participates in the review of the safety-related sections in the clinical trial documents.
• Develop and maintain the safety database and management system.
• Perform data analysis to evaluate safety signals and write up analysis results.
• Author aggregate reports (PBRERs, PSURs, DSURs, etc.) according to the agreed process and timelines as needed.
• Assist with database reconciliations and quality checks.
• Maintain current knowledge of adverse event reporting obligations to comply with new or updated regulations.
Number of Openings
1~2人
Educational Requirements
大學(學院)以上
Field of Study Requirements
生物學相關、醫學系相關、藥學相關
Work Schedule
日班
Leave Policy
週休二日
Job Category
Biotechnology Research and Development Staff
Pharmaceutical Research and Development Staff
Pathology and Pharmacology Research Staff
台北市大安區
其他醫療保健服務業
台灣雙健維康生技顧問有限公司為日本伊藤忠集團旗下 A2 Healthcare Corporation之台灣子公司，主要提供服務為全方位之臨床研究受託服務，包含醫學文件撰寫，台灣、美國及日本之主管機關或IRB送件，試驗監測，資料處理，EDC建置及統計分析服務。公司自2012年成立至今，已累計服務國內外逾45個客戶，執行逾100件臨床試驗。除國內執行之臨床試驗案外，尚包含在美國及日本送件及收案之研究案件。
