药物警戒专员/高级专员PV

缔脉生物医药科技(上海)有限公司

浦东新区-张江镇 | 3-4年工作经验 | 本科

2023-12-22发布

招聘人数:2人

15-20K/月

申请职位

职位信息

Position Summary Responsible for various types of drug safety case processing, assessment, reporting, review received from various sources to provide high quality safety service delivery to customers. Distribute reports and data to both internal and external parties following applicable regulations, SOPs and internal guidelines. Apply Knowledge and expertise in regulatory and safety reporting. Serve as principal owner of regulatory and safety reporting deliverables. Provide oversight on projects per requirement. Key Responsibilities - Provide professional and high-quality safety service delivery 1. Receive, triage, review and process safety data from various sources on time, within timeline and quality standards. Perform data entry, code relevant medical terminology, write descript narratives, generate queries pertinent to the case, perform quality control, assist with reconciliation, drive case closure, coordinate translations and ensure reportsare sent to the customer within assigned deadlines. 2. Receive and document incoming telephone calls, faxes or emails from investigative sites or other sources reporting safety data. 3. Assess safety data for report ability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines andin a format compatible to requirement. Liaise with customers or relevant parties to facilitate expedited reporting. 4. Process safety data according to applicable regulations, guidelines, SOPs and project requirements. 5. Contribute knowledge and expertise to or lead assigned deliverable in the field of regulatory reporting. 6. Serve as principal owner of regulatory deliverable and have responsibility for completion of the document in compliance with all applicable service level agreements. - Contribute to project management and team result 1. Liaise with customer and relevant parties, e.g. project management, clinical, data management, health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project issues and identify issue resolution. 2. May lead projects to ensure all activities are completed on time and meet quality standards. 3. Mentor less experienced or newer staff members. May provide oversight on operational activities and have a sound understanding of project protocol, therapeutic indication, resource needs, and scope of work (SOW) for assigned projects; set up and maintain project files, standards, templates, electronic forums, databases and workflow. 4. Manage project metrics, out of scope work, challenges, issues and successes. 5. Contribute to achievement of team and departmental goals e.g. utilization, productivity metrics. - Ensure compliance to regulatory and quality requirements 1. Ensure compliance to dMed high quality standards and works with PV Lead constructively in a matrix framework to achieve project and customer deliverables. 2. Participate in training across PV service offerings. Provide project-specific process training to junior team members, monitors and investigative site personnel, as appropriate. 3. Read and acknowledge all necessary dMed standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Education and Key Competency Requirements 1. Bachelor’s degree, in Life-science or Pharmaceutical discipline is preferred. 2. At least 1 year’s experience in drug safety and pharmacovigilance, or at least 3 years’ experience in related function (such as clinical operation, data management, regulatory affairs) Solid experience and knowledge of Pharmacovigilance processes or in particular pharmacovigilance function line; willingness and aptitude to learn new skills across Pharmacovigilance service lines. 3. Good understanding of applicable global, regional, local clinical resea

联系方式

上班地址:上海市浦东新区祥科路298号佑越国际3楼301-305

缔脉生物医药科技(上海)有限公司


•民营公司

• 少于50人

• 制药/生物工程

缔脉生物医药科技(上海)有限公司是一家临床合同研究组织(CRO),旨在为中国及全球生物医药公司和医疗器械公司提供高水准全方位的服务,以我们专业能力、全球经验、先进技术和创新方法确保临床试验符合科学规范和满足法规和监管要求。我们希望推动国内临床开发水平和技能的不断提升从而促进中国创新药物走向全球,同时我们也希望以创新致力于提高临床试验的规划和执行效率,从而最终增大客户药物和医疗器械的成功几率。缔脉聚集了大批具有国际视野的、在临床试验方面具有丰富经验的专业人才,我们的主营业务包括专家咨询、临床试验运营、生物统计与编程、数据管理、药物安全与警戒、临床科学与医学事务、质量保证、稽查及核查准备、法规事务和策略等。
查看该公司所有职位