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客户经理

安斯泰来制药(中国)有限公司

投递简历

10k-15k

学历:本科 | 工作年限:二年以上 | 年龄:年龄不限 | 意向:全职

工作地点: 北京市

职位描述


Accountability:

一、Collection, report and management of individual safety events and QC

1. To complete the English ICSR of the responsible products and report it to API PV (Group Company's Department of Pharmacovigilance)/business partners within the specified timeline.

2. To report safety events to the drug regulatory authority in accordance with provisions of laws and regulations.

3. To follow up adverse events by telephone etc. according to the requirements of API PV/business partners.

4. To implement ICSR files archiving related work.

5. To implement QC confirmation and related management of ICSR produced by other PV specialists in accordance with the SOP requirements.

二、Overseas Adverse Event Reporting

1. To regularly collate the list of overseas adverse events provided by API PV and translate it into a list that meets the requirements of Chinese laws and regulations;

2. To regularly collate the list of overseas adverse events provided by partners and translate it into a list that meets the requirements of China;

3. To report to national authorities within the time limit.

三、PV document production and training, and data translation

1. To draft or modify departmental WPD documents, implement document training for WPD-related personnel, maintain training records, and supervise the effectiveness of the implementation.

2. To translate PV-SOP, PSUR, AE summary report, PV agreement and other data as scheduled in a timely manner.

四、PV work related with product registration and updates

1. To assist the supervisor in preparation of AE summary of the responsible product, the review of the updated contents of the product labeling, and collation and report of relevant data of clinical trials.

五、PV training management and publicity

1. Under the guidance of supervisor, to implement the production of PV training materials, and training records collation and archiving following the SOP requirements.

2. According to the publicity and education plan, to complete designing, producing and arranging exhibitions of publicity materials and the related work.

六、Monthly Compliance Report production and communication

1. To assist the supervisor in the production of Monthly Compliance Report and communication with API. If necessary, make a CAPA plan and follow up to confirm the improvement results.

七、External customer consultation and related information processing

1. To answer and reply to PV/QA related reports/inquiries/complaints from the call center and internal staff.

2. To make the Chinese information report form and transfer it to the relevant person in charge and obtain a reply.

3. To produce and update FAQ under the guidance of PV medical consultants, and use it flexibly and archive timely.

4. To search and confirm the company's CC system daily, and timely find and process information related with drug safety and product quality.

八、Other

1. To receive necessary drug safety training and assessments to understand the latest news and knowledge of drug safety.

2. To complete other tasks assigned by the PV manager.




Qualifications:

一、Education

1. Bachelor degree or above in pharmacy, pharmacology or clinical medicine related majors.

二、Skills

1. Fluent English speaking and writing (required skills).

2. To understand drug safety related laws and regulations correctly.

3. Good learning, execution, problem analysis and solving abilities.

4. Good communication willingness and ability; ability to communicate effectively by telephone and in writing.

5. Ability to work carefully and seriously to ensure the accuracy and completeness of the information conveyed.

6. Good computer application skills

三、Experience

1. More than 1 year work experience in drug safety.

公司介绍


安斯泰来制药集团是一家总部位于日本东京的研发型制药企业,在全球范围内研发、生产、销售创新型医药产品。我们的使命是不断提升企业价值,致力于通过创新可靠的医药产品为全世界人民的健康做贡献实现我们的存在意义。
安斯泰来制药集团已经在器官移植领域和泌尿领域成为全球专业治疗领域领导者(GCL)。我们结合自身的研发实力,锁定了五个重点研发领域,包括免疫/感染、泌尿、肿瘤、神经科学和糖尿病合并症/代谢性疾病。
在2010财务年度 (2010 年 4 月至 2011 年 3 月) 全球净销售额达 9539 亿日元(97 亿美元)。安斯泰来已经成为日本第二大处方药品公司,全世界排名 20位的制药企业。目前全球员工约 16000 人。 如欲了解更多详细信息,请登录安斯泰来集团全球网站http://www.astellas.com/en/。

安斯泰来中国介绍:
安斯泰来制药(中国)有限公司(以下简称“安斯泰来中国”)是由原“山之内制药(中国)有限公司”于2005年8月更名,再于2007年4月1日,与“藤泽药品(中国)有限公司”合并而成。
安斯泰来中国以“通过提供创新而可靠的医药产品为世界人民的健康做贡献”为经营理念,秉持高度的伦理观和道德观,开展合乎法规的经营活动。在提升企业价值的使命下,发挥创造性,实现业务的持续发展,力图在中国成为受到客户、员工、相关企业、社会团体等利益相关者信赖的企业。
安斯泰来中国是安斯泰来制药集团在中国投资的全资子公司。工厂位于沈阳经济开发区,总部设在北京,在上海、北京、广州、成都、武汉、青岛和沈阳设有分公司,业务范围遍及全国大中城市,全国约有员工1000名。
安斯泰来中国目前在中国上市销售9个产品,涉及器官移植、泌尿、感染、皮肤、消化循环等多个专业领域,其中已经在器官移植和泌尿领域得到广大医生和患者的认可,处于市场领先地位。

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基本信息


公司性质:外资(非欧美)
公司规模:1000-5000人
公司地点:北京市朝阳区建国门外大街8号IFC大厦27层
行业类别:其他

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