求職服務專線
台北 02-2912-6104 轉 2
   02-7703-3104 轉 2
意見回饋
廠商求才專線
台北 02-2912-6104
   02-7703-3104
台中 04-3700-6104
上海 86-21-50277104 轉 1
意見回饋

Medical Writing Specialist/ Pharmacovigilance Specialist

  • 全職

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.

工作條件

  • 工作經歷: 一年以上
  • 學歷要求: 大學以上
  • 語文條件: 英文 -- 聽 /精通、說 /精通、讀 /精通、寫 /精通
  • 其它條件: 1. Should at least hold a bachelor's degree while a master's degree is preferred. Having a degree in life science, medical field, or clinical field is a plus.
    2. At least 1-year experience in the pharmaceutical industry or the clinical research related field.
    3. Experience with clinical and postmarketing safety preferred.
    4. Knowledge of MedDRA coding conventions and WHO Drug Dictionary.
    5. Extensive experience with software-based drug safety systems preferred.
    6. Strong knowledge of drug development and clinical trials, and strong proficiency in regulatory guidelines.
    7. Familiarity with MS office & Adobe Acrobat Professional and good working knowledge and experience of the Internet and search engines
    8. Highly organized, excellent time management and communiation skills are also required.
    9. Demonstrate ability to handle and prioritize a fluctuating workload.
  •  
  • 歡迎二度就業、中壯齡(45~54歲)

福利制度

*〈制度類〉*    
1. 年終獎金
2. 盈餘分紅
3. 中秋禮金
4. 端午禮金
5. 週休二日    
6. 優於勞基法之年假制度  
7. 彈性上下班制度
8. 順暢的升遷管道

*〈保險類〉*
1. 勞工保險  
2. 健康保險 
3. 勞工退休金提撥
4. 員工團體保險
(包括:意外傷害保險、意外傷害保險醫療、意外傷害住院醫療、團體職業災害傷害保險)

*〈其他〉* 
1. 年度員工旅遊
2. 年度員工健康檢查
3. 慶生活動
4. 不定期舉辦部門活動
5. 不定期舉辦公司活動
6. 結婚、生育、喪葬津貼
7. 完善舒適的辦公環境

更新日期:2022-01-24

應徵方式

  • 職務聯絡人: 張小姐
  • 聯絡E-Mail: (請利用104履歷表應徵此工作) 我要應徵
  • 洽: 不接受電洽
  • 洽: 不接受親洽

應徵分析

兩週內0-5人應徵
經歷分佈
新鮮人0%
1~3年0%
3~5年100%
5~10年0%
10年以上0%
學歷分佈
碩士及以上50%
大學50%
專科0%
高中0%
高中以下0%
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