药物警戒pv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

岗位职责：
1.负责收集、审查、评估、处理、跟踪、汇总本公司药物安全性信息
2、根据SOP及相关法律法规对SAE、ICSR、重要不良事件等进行处置报告
3、配合SOP及相关法律法规编写、报告药物安全性报告
4、公司安全性数据库的搭建、使用及维护
5、依据法规、公司、部门要求编制如标准操作规程(SOP)、工作指南等并负责相应的培训、指导
6、为临床研究提供相应药物安全性工作提供支持;完成公司领导交办的其他工作
7、能根据公司要求建立与三方服务机构的沟通交流机制，并能保证药物警戒符合GVP要求。
8、领导安排的其他工作
岗位要求
1.临床医学或药学等相关专业，本科以上学历;
2.具有药物警戒工作3年以上经验者优先，接受过药品不良反应监测和管理的专业知识培训;
3.具备充足的药物警戒及药物安全经验，充分了解药物/生物制药安全管理方面的国际国内法规;
4.熟悉国家相关法律法规及ICH、GCP等规范指南，熟悉临床试验过程，有严密的逻辑思维能力和很强的沟通协调能力，解决问题能力。
5.严谨的工作态度，良好的执行能力。
6.踏实肯学。

Reporting to:
Pharmacovigilance Manager
Position description:
Responsible fcarrying out the PV related work according to ICH-GCP, SOPs, project specific procedures, applicable regulatory requirements.
Responsibilities:
 Support to set up the related system safety database
 Support the PV related work in the clinical projects including but not limited to: case receipt, case processing, expedite/periodic reporting of safety information to regulatory authorities/investigators/IRBs/sponsors, the preparation of safety management plan as requested.
 Support to perform post-marketing PV service tasks including but not limited to: case handling, literature searching reviewing, expedited / periodic reporting of safety information to regulatory authorities/sponsors in compliance with regulatory timelines.
 Conduct the quality control of pharmacovigilance activities to ensure the data accuracy completion.
 Ensure the safety reports are delivered to the authority other stakeholders in a timely manner according to the regulations.
 Provide timely response to the PV related questions to the sponsors authorities if required.
 Communicate maintain a good relationship with the internal external stakeholders, such as the sponsors, investigators authorities.
 Handle the pharmacovigilance affairs according to the tasks assigned by the country PV officer.
 Support audits/inspections implement relevant CAPAs if necessary.
 Perform the tasks assigned by line manager.
Qualifications:
Education Experience:
 Bachelof pharmacy/nursing/medicine/biology a related major. A master degree is preferred.
 1 year above PV relevant experience is preferred
 Knowledge of clinical medicine is preferred.
Skills Competencies:
 Ability to quickly learn master local regulations, ICH related regulations essential knowledge about therapeutic areas, pharmacovigilance clinical trial.
 Proficient in the use of computer software such as MS office applications.
 Proficient in the use of safety data base (such as ARISg, ARGUS, CRSCube) are preferred
 Fluent in both writtenal English.
 Good interpersonal skills to professionally communicate with all levels of theganizations.
 Good time management & multi-task capability.