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所在学校:中国医科大学
宣讲地点:新校区公共教学楼A座礼堂
点击人次:3547
公司介绍 精鼎医药是一家致力于药物临床试验研究的CRO(Contract Research Organization)集团公司,成立于1982年,协助世界各国各大药厂从事新药研发及临床试验。 精鼎医药总公司位于美国,分支机构遍布全球50多个国家,并设有70多家分支机构,全体员工超过12000人,并于亚太地区包括台湾, 韩国,中国(北京,上海,成都,广州,沈阳),香港,印尼,泰国,马来西亚,新加坡,澳大利亚,印度,日本,菲律宾和越南等设有分公司或办事处,提供客户最专业和符合国际标准的临床研究委托服务。目前精鼎医药已成为亚太地区及国内规模最大, 服务项目最完整的专业CRO公司,并已在业界建立高品质的专业形象以及良好口碑。
公司简介:
精鼎医药是一家致力于药物临床试验研究的CRO(Contract Research Organization)集团公司,成立于1982年,协助世界各国各大药厂从事新药研发及临床试验。精鼎医药总公司位于美国,分支机构遍布全球50多个国家,并设有70多家分支机构,全体员工超过12000人,并于亚太地区包括 韩国,中国(北京,上海,成都,广州,沈阳,台湾,香港),印尼,泰国,马来西亚,新加坡,澳大利亚,印度,日本,菲律宾和越南等设有分公司或办事处,提供客户最专业和符合国际标准的临床研究委托服务。目前精鼎医药已成为亚太地区及国内规模最大, 服务项目最完整的专业CRO公司,并已在业界建立高品质的专业形象以及良好口碑。
岗位介绍
一、药物安全专员(20名)
7.5k~9.5k/沈阳/本科及以上(如:5k~7k/长沙/本科及以上)
需求专业:
医学/药学
岗位职责:
1、Performing clear and accurate data capture of Individual Case Safety Reports (ICSRs) (including serious and non-serious cases from spontaneous and clinical trials origin, literature and E2B cases; and veterinary cases, as applicable) and appropriate medical assessment (including company causality and assessment of expectedness) of ICSRs in accordance with client conventions/guidelines and Standard Operating Procedures.
岗位要求:
1、Degree in Science
Good knowledge of medical terminology
Fluency in written and spoken English and Japanese
Computer proficiency, an ability to work with web-based applications
Capability to make concise, accurate and relevant synopses of medical text and data, and the ability to write unambiguous medical text
Ability to evaluate data and draw conclusions independently
福利待遇:
1、带薪休假14天
2、每年一次旅游
联系方式:
联 系 人:Tony Feng
联系电话:024-31352303
联系邮箱:
联系地址:辽宁省沈阳市和平区青年大街286号华润大厦10楼1001室、1002室、1007室
20人
岗位职责:
工作职责:
The Statistical Programmer works closely with Data Operation groups to support various programming activities related to the statistical analysis and reporting of clinical study data.
Deliver best value and high quality service, Check own work in an ongoing way to ensure first-time quality, Maintain all supporting documentation for studies in accordance with WSOPs/Guidelines to ensure traceability and regulatory compliance
Ensure compliance with WSOPs/Guidelines, ICH-GCP and any other applicable local and international regulations and participate in internal/external audits and regulatory inspections as required, Use efficient programming techniques to produce high quality derived datasets, tables, figures and data listings.
职位要求:
Educated to BS or above degree level in the relevant discipline is preferred or equivalent work experience. (Statistics, Pharmacy, Mathematics, Mathematics, Computer Science, Biological science, or other health-related discipline preferred).
Experience in SAS
Knowledge of WSOPs/Guidelines/System Life Cycle methodologies, ICH-GCP and any other applicable local and international regulations such as 21 CFR Part 11 and proven practical application
Knowledge of the programming and reporting process within the Statistical Programming Department
Good in written and oral English.
Demonstrate ability to learn new systems and function in an evolving technical environment
Attention to detail
① 公司主页申请【推荐】:
(点击左下角“阅读原文”)
② 微信申请:精鼎医药招聘主页 → 精鼎招聘
③ 发送简历至: (邮件主题请注明“姓名+申请职位名称+工作地点”)
④ 其他合作网站申请:Linkedin / 51job / 智联招聘 / 大街网
精鼎医药 诚邀您的加入!
20人
岗位职责:
Basic Function: Responsible for capturing and assessing single adverse event
reports associated with client products on the client’s Drug Safety database, in
accordance with international and local regulatory requirements
Principal
Functional Responsibilities:
• Determining the category of information
received whether it is a Medical Inquiry, Product Quality Complaint (PQC),
an adverse event (AE) associated with a PQC, or an AE alone, and handling it
accordingly per the relevant SOPs and guidelines
• Creating/generating
AE/Product Complaint forms in the Product Complaint System
• Keeping track of
the Product Quality Complaints
• Performing clear and accurate data capture
of cases (including serious and non-serious cases from spontaneous and clinical
trials origin, literature and E2B cases, as applicable) and appropriate medical
assessment (including company causality and assessment of expectedness) of cases
in accordance with client conventions/guidelines and Standard Operating
Procedures
• Reviewing ancillary documentation accompanying the reports and
identifying the relevant information for processing and electronic capture in
the applicable database
• Maintaining an excellent knowledge of case
processing conventions and guidelines, client’s procedures and international
drug safety regulations
• Maintaining a good working knowledge of the AE
safety profile of assigned products and labeling documents
• Ensuring MedDRA
coding in accordance with “MedDRA Term Selection: Points to Consider”, where
applicable
• Maintaining an awareness of global regulatory reporting
obligations and organizing workload to ensure compliance with internal and
regulatory timelines for adverse event reporting
• Interacting with internal
or external contacts to resolve issues related to the processing of cases and
PQCs
• Responding to clients/customers in a timely manner
• Performing
triage of literature abstracts and/or full articles for validity, if
required
• Performing single case creation/initiation in the safety database,
if required
• Mentoring new recruits in the team, if required
•
Identifying areas of concern within the team and raising the issues with the
Team Lead
• Maintaining an awareness of the performance metrics measured by
client and striving to remain within established limits
Note: The above
statements describe the general nature and level of work being performed, and
are not an exhaustive list of all responsibilities required for the position.
Qualifications and Experience:
• Science/Medicine degree: The minimum
qualification required would be a University degree in Life Sciences (Pharmacy,
Microbiology, Biochemistry, Biotechnology, Biophysics etc.)
• A degree in
Medicine/Dentistry/Physiotherapy/Experimental Medicine, which involves patient
exposure in hospital based environment, would be an advantage
• Good
knowledge of medical terminology
• Fluency in written and spoken English,
Japanese, Chinese
• Computer proficiency, an ability to work with web-based
applications, and familiarity with the Windows Operating System and the MS
Office suite (Word/Excel/Power Point)
• Capability to make concise, accurate
and relevant synopses of medical text and data, and the ability to write
unambiguous medical text
• Ability to evaluate data and draw conclusions
independently
• Typing and transcription accuracy
• Team
player
*Job Qualifications
JP background
职位申请方式:
① 公司主页申请【推荐】:
(点击左下角“阅读原文”)
② 微信申请:精鼎医药招聘主页 → 精鼎招聘
③ 发送简历至: (邮件主题请注明“姓名+申请职位名称+工作地点”)
④ 其他合作网站申请:Linkedin / 51job / 智联招聘 / 大街网
精鼎医药 诚邀您的加入!
精鼎医药研究开发(上海)有限公司沈阳分公司
领域:科学研究和技术服务业
规模:150-500人
地址:沈阳市和平区青年大街286号华润大厦第10层01、02、07单元