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英语→中文简体生命科学/药物警戒语言学家(美国时区)

English to Chinese Simplified for Life Sciences / Pharmacovigilance Linguist (US Timezone)

其他全球可投
公司Weloglobal
薪资未公开
工作地点Remote
地域资格全球可投
时区要求无特别要求
用工类型Freelance-Remote
发布时间未知
数据来源Lever
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全球可投:该职位未限制候选人所在地区。仍需注意薪资可能按地区折算,以及实际签约方式(正式雇佣 / 独立合同)。

关于 Welo Life Sciences

Welo Life Sciences 是 Welo Global 品牌旗下公司,是一家专注于语言和技术解决方案的合作伙伴,服务于在受监管全球市场运营的制药、CRO 和医疗设备组织。我们提供符合监管要求的翻译、语言验证和本地化解决方案,支持临床试验、药物警戒、法规事务、标签和全球商业化。我们的方法结合了专业领域知识与 ISO 认证的质量流程及技术驱动的工作流程,旨在无缝集成到生命科学运营中。凭借丰富的全球产品开发和上市后要求支持经验,Welo Life Sciences 帮助组织加快时间进度,保护数据完整性,并在多种语言和地区保持合规性。所有解决方案均在安全、可审计的框架内交付,该框架获得七项 ISO 认证。welolifesciences.com

职位介绍

我们正在寻找有经验的英语到简体中文语言专家,需位于美国或能覆盖美国时区,以支持一家领先全球制药公司的新高吞吐量药物警戒项目。该项目围绕定期获益-风险评估报告(PBRERs)展开,要求严格的 24 小时不延长交付时间,包括周末。

这是一项预计于 2026 年 8 月底开始的新合作,作为持续的自由职业合作,每个项目的常规工作量为 30,000 至 60,000 字。

主要职责

  • 对定期获益-风险评估报告(PBRERs)和监管文件进行机器翻译后期编辑(MTPE),这些文件评估药品的累计安全性、有效性及获益-风险平衡,以及相关的药物警戒内容,从英文翻译为简体中文。
  • 满足严格的 24 小时不延长交付时间;项目请求可能随时到达,包括周末。
  • 在客户的 CAT 工具环境(XTM)中工作,遵循项目特定的设置说明。
  • 在需要时与其他语言专家协作完成同一项目,当工作量较大时需将任务分配给多个资源以满足截止日期,同时保持一致性和质量。

任职要求

  • 翻译、语言学或语言研究学位,或包含大量翻译培训的同等学位。
  • 至少 2 年的专业药物警戒文档翻译经验:SAE/AE(严重和非严重不良事件)。
查看英文原文

About Welo Life Sciences

Welo Life Sciences, a Welo Global brand, is a specialized language and technology partner serving pharmaceutical, CRO, and medical device organizations operating in regulated global markets. We deliver regulator-ready translation, linguistic validation, and localization solutions that support clinical trials, pharmacovigilance, regulatory affairs, labeling, and global commercialization. Our approach combines subject matter expertise with ISO-certified quality processes and technology-enabled workflows designed to integrate seamlessly into life sciences operations. With extensive experience supporting global product development and post-market requirements, Welo Life Sciences helps organizations accelerate timelines, protect data integrity, and maintain compliance across languages and regions. All solutions are delivered within a secure, audit-ready framework supported by seven ISO certifications.  welolifesciences.com

About the Role

We are looking for experienced English into Chinese Simplified linguists either based in United States or that could cover US time zone to support a new, high-volume pharmacovigilance program for a leading global pharmaceutical company. The program centers on Periodic Benefit-Risk Evaluation Reports (PBRERs) and carries a strict, non-extendable 24-hour turnaround time, including weekends.

This is a new engagement expected to start end of August 2026, running as an ongoing freelance engagement with regular volumes of 30,000–60,000 words per project.

Key Responsibilities

  • Perform Machine Translation Post-Editing (MTPE) of Periodic Benefit-Risk Evaluation Reports (PBRERs) and regulatory document evaluating a medicine's cumulative safety, efficacy, and benefit-risk balance and related pharmacovigilance content from English into Chinese Simplified.
  • Meet a strict, non-extendable 24-hour turnaround time; project requests may arrive any time of day, including weekends.
  • Work within the client's CAT tool environment (XTM) following project-specific setup instructions.
  • Collaborate with other linguists on the same project when volumes require work to be split across multiple resources to meet deadlines, while maintaining consistency and quality.

Requirements

  • Degree in translation, linguistics or languages studies or an equivalent degree that includes significant
  • translation training.
  • Minimum 2 years of professional experience translating Pharmacovigilance documents: SAE/AE (serious and non-serious adverse events), PSURs (Periodic Safety Update Reports), SUSARs (Suspected Unexpected Serious Adverse Reactions), ICSRs (Individual Case Safety Reports), DSURs (Development Safety Update Reports), or Risk Management Plans (RMPs).
  • Alternatively, minimum 2 years of experience translating regulatory or clinical documents such as medical reports, protocols, synopses, ICF, discharge reports, study reports, SmPC, PIL, or medical literature (articles/journals).
  • Able to commit at least 5 hours daily, including weekends, given the strict 24-hour TAT.
  • Comfortable working as part of a linguist pool on the same project, to meet volume and deadline requirements consistently.
  • Familiarity with CAT tools, XTM will be used and will be plus to have previous experience!
  • Reliable, deadline-driven, and available on short notice, project requests may come in at any time.
  • Based in the United States, or otherwise able to consistently cover US business hours.

Nice to Have

  • Prior experience on dedicated/embedded pharmacovigilance or safety programs with strict SLA-based delivery.
  • Experience translating PBRERs specifically.
  • Established capacity to track and report daily throughput for Operations/PM planning purposes.

Tools & Systems

  • CAT tool: XTM, client-provided license; onboarding and connector setup provided after onboarding.
  • There's an unpaid Pharmacovigilance test as part of our onboarding and quality process, please only apply if you're willing to complete it.

Job Reference: #LI-JC1

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