锦鲤求职岗位描述
岗位职责
岗位职责：
Responsible for PV related operations activities, including the processing and classification of pre-marketing and post-marketing ICSRs to ensure reporting timeliness and accuracy. Ensure that all PV activities conform to the requirements of laws and regulations of regulatory authorities and relevant SOPs of the company and are carried out in a timely and effective manner throughout the drug life cycle. Cooperate with department to set up and improve pharmacovigilance system according to laws and regulations, guidelines and company SOP requirements.
负责药物警戒相关运营活动，包括上市前和/或上市后的个例安全报告的处理和分类并保证报告的及时性和准确性。在整个药品生命周期中，确保药物警戒各项活动符合监管机构法律法规和公司相关SOP的要求，及时有效进行。依照法律法规、指南及公司SOP要求，配合部门建立、完善药物警戒体系。
1. Handling Individual Case Safety Reports, ICSRs (10%-40%)
个例安全报告的处理（10%-40%）
1） Reception of safety information from different sources, data entry, coding and narrative writing of ICSRs, submit reports within the submission timeline, ensure compliance with relevant laws and regulations, guidelines and company SOPs requirements.
不同来源安全性信息的接收，进行个例安全报告的录入、编码、撰写案例描述、在递交时限内完成报告的递交，确保符合相关法律法规、指南及公司SOP要求。
2） Quality control of ICSRs to ensure the accuracy and integrity of the reports.
对个例安全报告进行质量控制，确保报告的准确性与完整性。
3） Follow up missing key information and medical queries in ICSRs using medical, pharmaceutical and logical judgment according to the requirements of company SOPs.
根据公司SOP的要求，运用医学、药学及逻辑性判断，对个例安全报告中缺失的关键信息或者医学质疑进行随访。
4） Investigate death cases and group safety events, ensuring compliance with relevant laws, regulations, guidelines, and company SOPs;
负责对死亡病例和群体安全性事件进行调查，确保符合相关法律法规、指南及公司SOP要求；
2. Project Management (25%-50%)
项目管理（25%-50%）
1） Clinical Trial: Support project initiation, participate in investigator meetings and project initiation meetings, and provide pharmacovigilance related trainings; Develop safety management plan (SMP); Review cross-departmental documents such as clinical trial protocols, reconciliation plan, etc.; Participate in regular data review meeting; Participate in the data reconciliation between drug safety database and clinical trial database; Prepare and submit periodic line listing; Maintain good communication with cross-functional and third party companies to ensure the smooth progress of all work.
临床研究：支持项目启动，参与研究者会和项目启动会，提供药物警戒相关培训；制定安全管理计划（SMP）；审核研究方案、一致性核对计划等跨部门文档；参与项目安全性数据的定期审核；参与药物安全数据库与临床研究数据库的一致性核对；周期性行列表的准备与递交；与跨部门及第三方公司保持良好的沟通，确保各项工作顺利进行。
2） Assist in the formulation and implementation of drug intensive monitoring plan, ensuring that intensive monitoring projects meet the quality and time schedule requirements.
协助制定药品重点监测方案并实施，确保重点监测项目的质量和进度。
3） Participate in writing or reviewing relevant documents signed with the partners or vendors, manage the partners or vendors, and ensure that relevant responsibilities and obligations are fulfilled.
参与撰写或审阅与协议伙伴或供应商签订的相关文件，对协议伙伴或供应商进行管理，并确保要求履行相应职责与义务。
4） Supervise and manage investigator-initiated clinical trials and patient support programs, ensuring that PV activities are carried out in compliance with regulatory requirements.
监督管理研究者发起的临床研究和患者支持项目，确保相关药物警戒活动合规执行。
3. Signal Detection and Risk Management (5%)
信号检测和风险管理（5%）
1） Assist in supervising the implementation of risk management plans and make updates on a regular basis or according to the latest safety characteristics of the product
协助监管风险管理计划的执行，定期或根据产品最新安全性特征进行更新。
2） Responsible for regular literature review, grasp the latest product knowledge, especially safety information of the responsible product field or product, to ensure the relevant pharmacovigilance decisions are well grounded.
主要负责定期查阅文献，掌握所负责产品领域或产品的最新产品知识尤其是安全性信息，确保相关药物警戒决策有理有据。
3） Assist in signal evaluation and detection through database.
熟练使用数据库，协助进行信号评估和检测工作。
4. Periodic Reports (5%)
周期性报告（5%）
1） Assist in writing and reviewing periodic reports, including but not limited to development safety update report (DSUR) and periodic safety update report (PSUR).
协助撰写审阅周期性报告，包含但不限于研发期间安全性更新报告（DSUR）、定期安全性更新报告（PSUR）等。
2） Assist in the maintenance and management of periodic reports.
协助对周期性报告进行维护和管理。
5. Compliance Management (20%-40%)
合规管理（20%-40%）
1） Familiar with the submission requirements and timeline of ICSRs, periodic reports and other submission reports, and supervise the compliance of the products in charge.
熟悉个例安全报告、周期性报告和其他递交报告的递交要求和时限，监管所负责产品的合规情况。
2） Familiar with domestic and foreign laws, regulations and guidelines related to pharmacovigilance.
熟练掌握国内外药物警戒相关法律法规及指南要求。
3） Assist in writing and updating the company's pharmacovigilance related SOPs, and provide support for the continuous improvement of pharmacovigilance system.
协助撰写、更新公司药物警戒相关SOP，为药物警戒体系的不断完善提供支持。
4） Participate in or support internal, external and regulatory audits and inspections.
参与或支持公司内部、外部及监管机构稽查、检查。
5） Train and guide new colleagues or project members as a trainer to ensure that new colleagues or project members can meet the job requirements as soon as possible.
作为培训师对新同事或项目成员进行培训和指导，确保新同事或项目成员能够尽快满足岗位要求。
岗位要求
1. Bachelor degree or above, major in medicine, pharmacy, biology, etc.
本科及以上学历，医学、药学、生物学等相关专业
2. Familiar with domestic and foreign laws, regulations and guidelines related to pharmacovigilance.
熟悉国内外药物警戒相关法律法规及指南
3. At least 5 years experiences in pharmacovigilance
5年以上药物警戒相关经验
4. Excellent English listening, speaking, reading and writing skills are preferred.
英文听说读写能力优秀者优先。
5. Experience with drug safety database, such as Argus, is preferred.
有药物安全数据库使用经验，如Argus优先。
6. Good communication skills, time management skills, analysis skills, team work skills, and strong problem solving skills.
有较强的沟通能力、时间管理能力，分析能力，团队协作能力，同时有较强的问题解决能力。