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某500强外企招聘药品安全员

更新时间:2017-07-31
工作地点:北京朝阳区国贸2期
薪资待遇:税前8-12K 五险一金+补充医疗保险
工作职责:

1、 Prepares the respective submission documents to Health Authorities

2、 Supervision of proper flow of confirmations of receipt of documentation sent to the Health Authorities.

3、 Preparation and everyday distribution of respective Patient Safety documents.

4、 Participation in the verification process of data correctness in the global safety database.

5、 Verification of correctness and compliance of documentation sent to Patient Safety Department

6、 Preparation of the Patient Safety training materials (incl. confirmations) and logistic organization of these trainings· Editing (where required and as per request from Patient Safety Member) training materials· Preparation of confirmations, certificates, printing of training materials for participants

7、 Archiving all safety documentation as per respective policies, guidance and procedures.

8、 Verification and update of respective PS archiving system (incl. review, update, management)

9、 Monitoring of the compliance with support of PS Associate

10、Manage collection, processing, documentation, reporting and follow-up of all adverse events reports for all Novartis group products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc.

11、Record and track receipts, submissions and distributions of SAEs, SRs, Suspected Unexpected Serious Adverse Reaction (SUSAR).

12、Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR) to Local Health Authorities (LHA) and/or clinical operations.

13、Work with other local/global PS associates to ensure accurate evaluation of safety data.

14、Interact and exchange relevant safety information with LHA, PS associates, other functional groups and third party contractor, if applicable.

15、Survey and monitor national pharmacovigilance regulations and provide update to global PS organization.

16、Support in developing, updating and implementing local procedures to ensure compliance with PS global procedures and national requirements.

17、Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.

18、Perform reconciliation with other departments (e.g. Medical Information, Quality Assurance and third party contractor, if applicable) for potential AEs resulting from medical inquiries, quality related complaints and other sources.

19、Management and maintenance of all relevant PS databases.

20、Prepare and submit KPI reports on compliance in a timely manner including identification of root cause(s) for late reporting to LHA, development and implementation of corrective action(s) as needed.


任职资格:

1、 Fluent in both written and spoken EnglishTOEIC 780 at least.

2、 Fluent in both written and spoken local language

3、 Experience on similar position in drug safety or drug registration or clinical research department would be an additional asset.

4、 Proven ability to work in cross-functional teams

5、 Computer skills (e.g. Excel, Word, Power Point) and ability to learn new systems quickly.

用工形式:此职位采用外包用工形式,与FESCO签订劳动合同。有意者请向wang.wen.yue@fesco.com.cn发送简历,标题请注明应聘职位
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