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更新于 2025-06-10 01:21:59

Syneos Safety & PV Specialist/藥物警戒專(zhuān)員 - 日語(yǔ)組

1.1-1.7萬(wàn)
  • 大連甘井子區(qū)
  • 1-3年
  • 本科
  • 全職
  • 招5人

職位描述

藥品警戒不良事件醫(yī)學(xué)評(píng)估臨床試驗(yàn)安全臨床研究醫(yī)藥制造
主要負(fù)責(zé)日本國(guó)內(nèi)case processing Data entry部分業(yè)務(wù) Location: 大連office-based or 其他城市home-based JOB SUMMARY Performs all aspects of the collection, processing, and reporting of individual cases safety reports (ICSR), adhering to all data privacy guidelines, Good Clinical Practices (GCPs), Good Pharmacovigilance Practice (GVP), regulatory guidelines, company and project/program-specific procedures for clinical trials and/or post-marketing safety programs. JOB RESPONSIBILITIES -Enters information into PVG quality and tracking systems for receipt and tracking ICSR. May assist in the preparation of the Safety Management Plan. Processes ICSRs according to Standard Operating Procedures (SOPs) and project/program-specific safety plans. 1)Triages ICSRs, evaluates ICSR data for completeness, accuracy, and regulatory report ability. 2)Enters data into safety database. 3)Codes events, medical history, concomitant medications and tests. 4)Compiles complete narrative summaries. 5)Assesses information to be queried and follows up until information is obtained and queries are satisfactorily resolved. 6)Participates in the generation of timely, consistent and accurate reporting of expedited reports in accordance with applicable regulatory requirements. 7)Coordinates with data management staff concerning reconciliation of safety data between the clinical and safety databases. -Ensures distribution of all required individual expedited and periodic reports for both clinical and post-marketing projects to the Safety Submissions team if contracted to submit the reports. -Participate in audits/inspections as required -Ensures all relevant documents are submitted to the Trial Master File (TMF) as per company SOP/Sponsor requirements for clinical trials and the Pharmacovigilance System Master File for post-marketing programs as appropriate. -Maintains understanding and compliance with SOPs, Work Instructions (WIs), global drug/biologic/device regulations, GCPs, ICH guidelines, GVP, project/program plans and the drug development process. QUALIFICATION REQUIREMENTS -Bachelor’s Degree in life science, registered nurse, pharmacist or an equivalent combination of education and experience that gives the individual the necessary knowledge, skills and abilities to perform the job. -Good in English & Japanese (English CET4 level or above & Japanese N2 level or above) -Safety Database systems and knowledge of medical terminology required. -Good understanding of clinical trial process across Phases II-IV and/or post-marketing safety requirements, ICH GCP, GVP and regulations related to Safety and Pharmacovigilance. -Proficiency in Microsoft Office Suite (Word, Excel and PowerPoint), Visio, email (Outlook), TeamShare (or other management/shared content/workspace) and internet. -Ability to work independently and in a team environment. -Good communication and interpersonal skills, both written and spoken. -Good organizational skills with proven ability to prioritize and work on multiple tasks and projects. -Detail oriented with a high degree of accuracy and ability to meet deadlines. -Minimal travel may be required (up to 5%)

工作地點(diǎn)

大連甘井子區(qū)騰飛園區(qū)

職位發(fā)布者

JeremyGu/TA

昨日活躍
立即溝通
公司Logo賽紐仕醫(yī)藥咨詢(xún)(上海)有限公司
Syneos Health賽紐仕醫(yī)藥是一家全面整合生物制藥解決方案的公司,旨在幫助客戶(hù)加快推出新療法的速度。我們站在產(chǎn)品研發(fā)的角度,戰(zhàn)略性地融合臨床研發(fā)、醫(yī)學(xué)事務(wù)和商業(yè)能力,以及時(shí)應(yīng)對(duì)市場(chǎng)變化。Join a game-changing company that is reinventing the way therapies are developed and commercialized. Created through the merger of two companies, INC Research and inVentiv Health, we bring together more than 22,000 clinical and commercial minds to create a better, smarter, faster way to get biopharmaceutical therapies into the hands of patients who need them most. Evolve in a global company that is always looking for ways to work smarter and more efficiently as the only fully integrated Biopharmaceutical Accelerator. You'll be supported with comprehensive resources based on today's emerging technologies, data, science and knowledge- instead of practices from the past. Teaming with some of the most talented professionals in the industry, you'll gain exposure and work in a dynamic environment to over-deliver and outperform. A career with Syneos Health means your everyday work improves patients’ lives around the world.
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