北京 [切换城市] 北京招聘

药物警戒专员(英语)Operations specialist 1

艾昆纬医药科技(上海)有限公司

  • 公司规模:500-1000人
  • 公司性质:外资(欧美)
  • 公司行业:制药/生物工程

职位信息

  • 发布日期:2024-02-01
  • 工作地点:大连
  • 工作经验:1年及以上
  • 学历要求:本科
  • 职位月薪:8千-1万·13薪
  • 职位类别:药物警戒专员(英语)Operations specialist 1

职位描述

岗位要求:
至少1年以上PV经验,具有生物医药专业背景优先
也可考虑应届生,或有医药行业其他工作经验,但必须具有生物医药相关专业背景
英语CET6优先, 读写流利,口语流利优先
Key Responsibilities:
· Process Safety data according to applicable regulations, guidelines, Standard Operating procedures (SOPs) and project requirements.
· To perform Pharmacovigilance activities per project requirement including but not limited to, collecting and tracking incoming - Adverse Events (AE)/endpoint information
· Perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes review of AE coding, past medical history, concomitant medications, expectedness/listedness, causality assessment and other medical information and ensure completeness and accuracy of data according to applicable regulations and guidelines, SOPs, project-specific guidelines, and medical evaluation guidelines and communicate with the team leads for any correction required in the case and maintain appropriate documentation for all communications.
· Determining initial/update status of incoming events
· Database entry
· Ensure to meet quality, productivity, and delivery standards per project requirements.
· Ensure compliance to all project related processes and activities.
· Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects
· Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.
· Liaise with different functional team members, e.g. project management, clinical, data management, healthcare professionals, e.g. investigators, medical monitors, site coordinators and designees to address project related issues.
· Liaise with client in relation to details on day-to-day case processing activities.
· To mentor new teams members, if assigned by the Manager.
· Attend project team meetings and provide feedback to operations manager on any challenges/issues or successes.
· Perform other duties as assigned.

Key Requirements:
? Bachelor’s Degree in Pharmacy, Nursing or equivalent Scientific or healthcare discipline or allied life sciences
? Experience in Pharmacovigilance in Pharma industry will be an advantage.
? Good knowledge of medical terminology.
? Working knowledge of applicable Safety Databases and any other internal/Client applications.
? Knowledge of applicable global, regional, local clinical research regulatory requirements.
? Excellent attention to detail and accuracy, maintain high quality standards.
? Good working knowledge of Microsoft Office and web-based applications.
? Strong organizational skills and time management skills.
? Strong verbal/written communication skills. Fluent in English, Mandarin, Cantonese and Malay is preferred.
? Self-motivated and flexible.
? Ability to follow instructions/guidelines, utilize initiative and work independently.
? Ability to multi-task, meet strict deadlines, manage competing priorities and changing demands.
? Ability to be flexible and receptive to changing process demands.
? Flexibility to operate in shifts and holiday coverage

公司介绍

IQVIA(纽交所代码:IQV)是全球专注生命科学领域的高阶分析、技术解决方案和临床研究服务供应商。IQVIA利用深入分析、前沿技术、大数据资源和广泛领域的专业知识,智能连接医疗生态的各个环节。IQVIA Connected Intelligence?快速敏锐地为客户提供强大的数据洞察,帮助客户加速创新医疗的临床开发和商业化进程,以更好的医疗成果惠及患者。IQVIA拥有约72,000名员工,足迹遍布100多个国家/地区。

IQVIA拥有多元化的加强型隐私技术和保障手段,能够在保护个人隐私的同时对信息进行管理和分析,帮助医疗利益相关方有效开展精准疗法,获得更佳的疗效。这些洞见和能力能够帮助生物科技、医疗器械、制药公司、医学研究者、政府机关、支付方以及其他医疗利益相关方,获得对疾病、人类行为和科技进步更深入的理解,共同朝着治愈各类疾病的方向迈进。

联系方式

  • Email:chinacampus@iqvia.com
  • 公司地址:越华路112号珠江国际大厦
  • 电话:13522411136