药物警戒专员

该职位来源于猎聘 【该岗位需要英语作为工作语言，工作中将频繁与海外团队沟通合作】

1.0概述 药物警戒专业项目经理与PV生产团队合作，在患者安全的背景下，根据客户对病例审查的要求，分析和报告安全参数。该专家还负责公司文献监测项目的日常协调和行政支持。该角色为更广泛的生产团队提供必要的支持，帮助确保满足所有客户的时间表和可交付成果。 2.0描述 执行各种任务以支持客户的临床研究，包括：不良事件分析和处理 准备安全报告，提交给各个卫生部门 通过遵循良好文件编制规范（GDP）标准，维护数据完整性并促进审计合规性 遵守项目时间表，根据需要与团队领导和项目经理积极沟通 理解并遵守适当的惯例和其他管理机构，遵循适用的部门指导方针、模板和标准操作程序（sop） 分析与安全报告相关的利益相关者投诉，实时处理，并与项目经理讨论以降低风险并实施/推动解决方案 完成经理/主管分配的其他适合本职位的任务 监督非语言药物警戒项目的行政方面，包括但不限于文件传输、内部流程检查和平衡以及客户交付 监控和沟通项目进度，确保严格遵守时间表并提供高质量的产出 与高级团队成员合作，确保客户的顺利和及时交付 3.0所需技能 了解常见毒性标准（CTC）和/或MedDRA编码 具备良好临床规范（GCP），良好文件规范（GDP）和国际协调会议（ICH）指南的知识

• 熟练使用Word、PowerPoint、Excel、Outlook、EndNote以及PubMed、Embase等科学数据库。 优秀的英语书面和口头沟通能力 注意细节，遵守标准操作规程和客户规范 学习和适应新技术和新系统的能力 良好的解决问题和批判性思维能力 扎实的组织和时间管理能力 所要求的经验和资格: 最少本科或同等学历 具有与跨职能团队合作的经验 医疗经验和至少1年的药物警戒经验 药学博士，生命科学学士 所需的技能和经验
• 有药物开发/临床试验经验 创造性思考者——好奇心强，不怕问问题 勤奋的人——做任何事都很勤奋 创新者——愿意发起变革并引入新想法

1.0OVERVIEW The Pharmacovigilance Specialized Project Manager collaborates with the PV production team to analyze and report on safety parameters, within the context of patient safety against our clients’ products, and in line with client requirements for case review. The specialist is also responsible for the day-to-day coordination and administrative support of TransPerfect’s literature monitoring projects. The role provides essential support to the broader Production team, helping to ensure that all client timelines and deliverables are met. 2.0DESCRIPTION Perform various tasks in support of our clients’ clinical research including: adverse event analysis and processing Prepare safety reports for submission to various health authorities Maintain data integrity and promote audit compliance by following Good Documentation Practice (GDP) standards Adhere to project timelines, with proactive communication with Team Lead and Project Managers, as needed Understand and comply with appropriate conventions and other governing bodies following applicable divisional guidelines, templates, and Standard Operating Procedures (SOPs) Analyze stakeholder complaints related to safety reporting, address in real time, and discuss with Project Managers to mitigate risk and implement/drive solutions Complete all other tasks that are deemed appropriate for this role and assigned by the manager/supervisor Oversee administrative aspects of non-linguistic Pharmacovigilance projects, including but not limited to file transfers, internal process checks and balances, and client deliverables

Monitor and communicate project progress, ensuring strict adherence to timelines and the delivery of high-quality outputs

Collaborate with senior team members to support smooth and timely client deliveries

3.0REQUIRED SKILLS Knowledge of Common Toxicity Criteria (CTC) and/or MedDRA coding Knowledge of Good Clinical Practice (GCP), Good Documentation Practice (GDP), and International Conference on Harmonization (ICH) guidelines

Proficiency in Word, PowerPoint, Excel, Outlook, EndNote, and scientific databases including PubMed, Embase, etc. Excellent written and oral communication skills in English Strong attention to detail and adherence to SOPs and client specifications Ability to learn and adapt to new technologies and systems Good problem-solving and critical thinking skills Solid organizational and time-management skill 4.0REQUIRED EXPERIENCE AND QUALIFICATIONS Minimum Bachelor degree or its equivalent

Experience in working with collaborative, cross-functional teams Medical experience and minimum 1-year Pharmacovigilance experience Doctor of Pharmacy (Pharm D), Bachelor in Life Sciences 5.0DESIRED SKILLS AND EXPERIENCE Drug development/clinical trial experience Creative thinker – Curious and unafraid to ask questions Hard worker – Industrious and diligent in everything you do Innovator – Willing to initiate changes and introduce new ideas