药物警戒岗位职责

Roles and Responsibilities1. Manage collection, processing, documentation, reporting and follow-up of all adverse eventreports for all Novartis products from clinical trials, non-interventional studies, Patient Oriented Programs, literature, Spontaneous Reports, etc. Transcribe, translate and enter data of all data from source documents into safety systems accurately and consistently with emphasis on timeliness and quality.2. Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE, SR, IN/SUSAR, PSUR, Biannual SUSAR Listing, DSUR, pharmacovigilance annual report) to Local Health Authorities (LHA) and/or clinical operations in cooperation with other Country Organization Departments.3. Work with other local/global Patient Safety associates to ensure accurate evaluation of safety data.4. Interact and exchange relevant safety information with LHA, Patient Safety associates, other functional groups and third party contractor, if applicable.5. Survey and monitor national pharmacovigilance regulations and provide update to global Patient Safety organization.6. Develop, update and implement local procedures to ensure compliance with Patient Safety global procedures and national requirements.7. Input, review and approval of program proposals for language, content and establishment of necessary controls on collection and reporting of adverse event information.8. 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.9. Management and maintenance of all relevant Patient Safety databases. 10. Ensure that relevant local literature articles are screened as appropriate.11. 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.12. Develop and update training materials for pharmacovigilance and ensure training of Country Organization associates on relevant Patient Safety procedures for AE reporting, including field force and third party contractor, if applicable.13. Ensure support for and close-out of audits, corrective action plan, investigation and Health Authority inspections.14. Ensure training and oversight of staff, as applicable.15. Manage and maintain efficient Patient Safety filing and archive system.16. Review of all Phase IV Clinical Trial and NIS protocols safety sections and if a Contract Research Organization (CRO) is conducting the trial, review the contract (SSW), train the CRO associates responsible from the trial Ideal Background Education (minimum/desirable): Health Care Sciences Professional (e.g. Medical Doctor, Nurse, Pharmacist) or equivalent education, training and experienceLanguages: • Fluent in both written and spoken English• Fluent in both written and spoken local languageExperience/Professional requirement:• Knowledge of national and international regulations for pharmacovigilance• Knowledge of pharmacological and medical terminology.• Excellent communications, interpersonal and negotiation skills• Quality and focus oriented• Computer skills• Additional educational requirements as may be mandated by national requirements

药物警戒职位描述：具体面谈岗位职责1根据公司情况协助上级完成药物警戒相关条例的制定与实施；2对公司药品不良事件进行收集、分类和整理，生成不良事件报告并进行分析、评价以及调查；3按照管理规定，将不良事件报告在规定时间内上报相关监管机构和部门，并对其进行跟踪和报告；3对药物警戒部门的相关文件以及签署的培训记录进行存档以及维护；5协助撰写定期安全性更新报告及药物警戒相关的报告；6根据计划对公司相关员工进行药物警戒知识的培训。岗位要求1、大专及以上学历，药学、生物学、化学及中药学相关专业；2、1年及以上药物警戒岗位工作者经历。3、文字表达能力强，能熟练撰写报告；熟练掌握常用办公软件的操作。
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岗位职责:
Regulatory Compliance
•Responsible fdata collection, processing, documentation, reporting follow-up of required adverse events (AE) reports within required timeline quality fassigned projects;
•Tracking archiving all safety reports documents;
•Ensure compliance of PV audit inspection in routine job periodically review to track, take action close audit finding;
•Notify line manager (LM) of significant issues in a timely manner.
MonitManage Investigational Marketed Products Safety
•Proactively review evaluate the clinical implications of safety data from different source fassigned projects;
•Review protocols, IBs all safety sections of clinical and/regulatory submission documents;
•Draft, review SAE case follow up queries;
•Draft SUSAR notification letter;
•Responsible fregulatory submission fsafety expedited report within required timeline quality.
•Implement other safety monitresponsibilities assigned by LM;
任职要求:
•BachelDegree in Medicine/Master PhD preferred
•Fluent written spoken English Chinese
•Computer Skill: Computer literacy, knowledge with
•Medical PV knowledge experience required
•Good knowledge of ICH, FDA EMA PV regulatory requirement
•Good problem solving skills, communication skills ability to learn new knowledge
•Good player to work both with a team as well as independently