For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners' most high-profile drug and device programs.
The Multilingual Medical Information Specialist (MMIS) position is part of the ProPharma Medical Information Contact Center and follows all corresponding regulations, industry standards, and client/internal policies regarding medical information and the collection and documentation of adverse events, special situation events, and product complaints
多语种医学信息专员(MMIS) 隶属于 ProPharma 医学信息联络中心,需遵循所有与医学信息相关的法规、行业标准以及客户和公司内部政策,包括不良事件、特殊情况事件及产品投诉的收集与记录要求。
Essential Functions Include:
Medical Information service delivery
* Responds to unsolicited consumer, health care professional and other external customer requests for medical and safety information received via telephone, website/e-mail, letter, fax, and scientific meetings on behalf of ProPharma` s pharmaceutical clients.
* Provides labeled and unlabeled medical/safety information responses in accordance with regulatory requirements, industry standards and client and ProPharma internal policies and practices.
* Accurately identifies, documents and reports adverse events, pregnancy reports, special situation events and product complaints in a clear and concise manner per government regulations, ProPharma`s Standard Operating Procedures (SOPs) and client Working Practices (WPs).
* Translating English documents into the target language or vice versa and delivering these translated responses either on the phone or in writing.
* Ensures tasks are completed within the deadlines documented in the agreed ProPharma SOPs and WPs.
* Formulates and provides accurate responses utilizing approved labeling and company standard responses, published literature and other data. Assists with writing custom medical information responses utilizing this data.
* Logging all enquiries handled in an accurate, comprehensive, and timely fashion into Inquiry Handling Systems.
Quality Assurance
* Maintains quality in all areas of the job, including performing quality checks on Adverse Events, Product Quality Complaints, correspondence, and enquiries logged into the Inquiry Handling Systems
* Quality checking translations in line with the translation SOP.
General
* Provides after-hours coverage on a rotated basis subject to business requirements.
* Adheres to company and country-specific privacy policies, ensuring any confidential information or personal data related to ProPharma and its clients is managed in accordance with Data Privacy regulations described in ProPharma SOPs and the Confidentiality Statement within the Contract of Employment.
* Complies with the Company's health and safety policies.
* Other activities as assigned as delegated by the Manager.
主要职责包括:
医学信息服务
* 代表 ProPharma 的制药公司客户,通过电话、网站/电子邮件、信函、传真及学术会议等渠道,回应消费者、医疗保健专业人士及其他外部客户主动提出的医学及安全性信息咨询。
* 根据监管要求、行业标准以及客户和 ProPharma 的内部政策与流程,提供已批准的说明书内及说明书外的医学/安全性信息回复。
* 按照政府法规、ProPharma 标准操作流程(SOP)及客户工作规范(WP),准确、清晰、简明地识别、记录并上报不良事件、妊娠报告、特殊情况事件及产品投诉。
* 负责英语与目标语言之间的文件翻译,并通过电话或书面形式向客户提供翻译后的回复。
* 确保所有任务在 ProPharma SOP 及 WP 规定的时限内完成。
* 使用已批准的产品说明书信息、公司标准回复、已发表文献及其他相关数据,制定并提供准确的医学信息回复;并协助基于上述资料撰写定制化医学信息回复。
* 将所有已处理的咨询准确、全面且及时地记录至咨询处理系统中。
质量保证
* 在所有工作环节中保持高质量标准,包括对不良事件、产品质量投诉、往来函件及录入咨询处理系统的信息进行质量检查。
* 根据翻译相关 SOP 对翻译内容进行质量审核。
一般职责
* 根据业务需要,轮班提供非工作时间(下班后)的支持服务。
* 遵守公司及所在国家的数据隐私政策,确保与 ProPharma 及其客户相关的所有机密信息和个人数据,均按照 ProPharma SOP 中所述的数据隐私法规及劳合同中的保密声明进行管理。
* 遵守公司的健康与安全政策。
* 完成直属经理指派的其他相关工作。
Qualified candidates must have:
* Life science degree OR Nursing degree (RN/BS/BA/MS) OR Pharmacy degree
* Mother tongue in target language.
* Fluent in English.
* Strong translation skills.
* Excellent verbal and written communication skills, including proofreading, professional telephone etiquette and empathetic customer service skills.
* Ability to write in a fluent and grammatically correct manner in the target language for the role
* English language proficiency.
* Working knowledge of medical terminology, pathophysiology, pharmacology, regulations and industry standards.
* Strong cognitive abilities, including verbal reasoning, critical thinking and analytical ability.
* Ability to multitask with attention to detail within restrictive timeframes, including sound planning, prioritizing and organizational skills.
* Proactive with demonstrative ability to independently identify problems and suggest effective solutions.
* Ability to learn, take instruction and apply to daily operations/tasks.
* Receptive to constructive feedback and able to take responsibility for work allocated.
* Self-motivating. Ability to demonstrate initiative and internal drive. Willingness to seek out additional workload projects.
* Effectively work independently and as part of a team.
* Highly proficient in computer applications, including Microsoft Office software platforms and Adobe Acrobat, and experience using a document management system. Aptitude to learn other computer systems including inquiry handling database.
任职资格要求:
* 生命科学相关学位,或护理学学位(RN/BS/BA/MS),或药学学位。
* 目标语言为母语。
* 英语流利。
* 具备优秀的翻译能力。
* 具备出色的口头及书面沟通能力,包括校对能力、专业电话沟通礼仪及富有同理心的客户服务技巧。
* 能够使用目标语言进行流畅且语法正确的书面写作。
* 具备医学术语、病理生理学、药理学、相关法规及行业标准的基础知识。
* 具备较强的认知能力,包括语言理解能力、批判性思维及分析能力。
* 能在时间限制较严的情况下同时处理多项任务,并保持高度的细节关注能力,具备良好的计划、优先级管理及组织能力。
* 积极主动,能够独立发现问题并提出有效解决方案。
* 具备良好的学习能力,能够接受指导并将其应用于日常工作。
* 乐于接受建设性反馈,并能够对分配的工作承担责任。
* 具备自我激励能力,能够主动展现积极性和内在驱动力,并愿意承担额外项目或工作任务。
* 能够高效地独立工作,同时具备良好的团队合作能力。
* 熟练使用计算机应用软件,包括 Microsoft Office、Adobe Acrobat,并具备文档管理系统使用经验;能够快速学习并使用其他计算机系统,包括咨询处理数据库。
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***