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Operation Specialist 2

艾昆纬医药科技(上海)有限公司
14K-16K |  大连市-高新区 |  工作经验: 3-5年 |  学历: 本科 |  语言: 韩语/朝鲜语 英语/四级

职位亮点:双休/五险一金,福利齐全。

发布时间:10天前

Job Overview

Apply knowledge and expertise including complex decision making activities to review, assess and process Safety data and information across service lines. Recognized as specialist in one or more areas. Provide oversight on small to medium service operational projects and act as mentor to junior members of staff.


Essential Functions

? 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

? determining initial/update status of incoming events

? database entry

? coding AE and Products, writing narratives, Literature related activities, Quality review, assisting with reconciliation, case closure related activities, coordinating translations, as per internal/ project timelines. Creating, maintaining and tracking cases as applicable to the project plan.

? Perform activities related to adjudication as applicable

? Assess Safety data for reportability to relevant authorities, track reportable cases and report to regulatory authorities, ethics committees, institutional review boards, investigators, oversight groups per legislation, within timelines and in a format compatible to meet requirement as per project. Liaise with relevant stakeholders to facilitate expedited reporting.

? Liaise with manager for regulatory tracking requirements and electronic reporting.

? Contribute knowledge and expertise to or lead assigned deliverables in the field of Safety Publishing, Risk Management, Safety Surveillance and Medical Information or other service lines as appropriate.

? Ensure to meet quality, productivity and delivery standards per project requirements.

? Ensure compliance to all project related processes and activities.

? Build a positive, collaborative team environment with Safety team members, lead by example, provide training and mentoring for less experienced team members and operations staff, assist Operations Manager as a backup when needed.

? Provide and impart technical and process information to Safety Management and members of operational team on project specific issues.

? Provide oversight role and have a good understanding of operational team on status, metrics, productivity and initiatives.

? Maintain a thorough understanding of project protocol, therapeutic indication, budget and scope of work (SOW) for assigned projects

? set up and maintain project files, standard templates, electronic forms, databases and workflow as per project requirement.

? Establish and maintain effective team and project service operations communications i.e. provide regular feedback to operations team manager and other relevant stakeholders on project metrics, out of scope work challenges/issues and successes

? effective feedback on project performance to junior members of team.

? Read and acknowledge all necessary IQVIA standard operating procedures (SOPs) and customer SOPs as required. Ensure all required training is executed in a timely fashion and documented. Work towards ensuring completeness of individual training plan and maintain up to date training transcripts.

? Participate or Lead trainings across Safety process service offerings

? participate in working groups as applicable in implementation of new initiatives, identification and implementation of process efficiencies.

? To demonstrate problem solving capabilities.

? Liaise with different functional team members, e.g. project management, clinical, data management

? health care professionals e.g. investigators, medical monitors, site coordinators and designees to address project related issues.

? Attend project team meetings and provide regular feedback/ inputs to Operations team manager on operational project metrics, out of scope work challenges/issues and successes.

? To liaise with client in relation to details on day to day activities as needed.

? Contribute to achievement of departmental goals

? Perform other duties as assigned

? 100% compliance towards all people practices and processes

? In addition to the above mentioned responsibilities, depending on the project requirement, the team member may perform medical review of non-serious adverse events (AEs) and non-serious adverse drug reactions (ADRs) which includes reviewal 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.


Qualifications

? Bachelor's Degree Scientific or healthcare discipline or allied life sciences Req

? Bachelor's degree in life sciences or related field and up to 5 years of relevant experience, inclusive of up to 3 years of Pharmacovigilance experience. Req

? or equivalent combination of education, training and experience. Pref

? Excellent knowledge of medical terminology. Intermediate

? In depth knowledge and understanding of applicable Safety Database and any other internal/Client applications. Advanced

? In depth knowledge and understanding of applicable global, regional, local clinical research regulatory requirements. Advanced

? Excellent organizational skills, time management skills, attention to detail and accuracy. Advanced

? maintain high quality standards. Advanced

? Excellent working knowledge of Microsoft Office and web-based applications. Intermediate

? To demonstrate effective project management and leadership skills. Intermediate

? Effective mentoring and coaching skills. Advanced

? Excellent verbal/written communication skills. Advanced

? Self-motivated, flexible, receptive to changing process demands. Advanced

? willingness and aptitude to learn new skills across Safety service lines. Advanced

? Proven ability to work independently and autonomously with policies and practices. Advanced

? Proven ability to multi-task, meet strict deadlines, manage competing priorities. Advanced

? Ability to identify, prioritize tasks and delegate to team members. Advanced

? Ability to establish and maintain effective communication and working relationships with coworkers, managers and clients. Advanced

? Ability to work as a Team Player, contribute and work towards achieving Team goals. Advanced

? Demonstrate Sound judgment and decision making skills. Advanced

? Ability to work effectively on multiple projects simultaneously, organize own workload and effectively manage teams’ priorities. Intermediate

? Ensure quality of deliverables according to the agreed terms. Advanced

? Demonstration of IQVIA core values while doing daily tasks. Advanced

? Skill to plan work load based on available capacity and ability to change prioritization based on workload fluctuations. Intermediate

? Skill to negotiate and work on finding a central ground that is satisfactory to all concerned stake holders. Intermediate

? Support audit preparedness Advanced

? Extensive use of telephone and face-to-face communication requiring accurate perception of speech. Intermediate

? Regular sitting for extended periods of time. Intermediate

? May require occasional travel. Intermediate

? Flexibility to operate in shifts. Advanced

IQVIA 艾昆纬是艾昆纬医药科技(上海)有限公司旗下品牌。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。


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艾昆纬医药科技(上海)有限公司
规模:500-2000人
领域:医疗科技
官网: https://www.iqvia.com/
公司地址:上海市浦东新区城区耀龙路 1359 号晶耀商务广场1幢9 楼
工作地址:辽宁省大连市高新区高新技术产业园区汇贤园 1 号楼 10 层

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