出海雷达

Drug Safety Associate

其他限定地区(需当地身份)
公司AmerisourceBergen
薪资未公开
工作地点Canada
地域资格限定地区(需当地身份)
时区要求日间重叠约 6 小时,基本正常作息
用工类型Full Time
发布时间今天
数据来源Himalayas
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注意地域限制:该职位明确限定在 Canada 招聘。如果你是位于中国大陆的求职者,通常需要当地工作身份才能投递,或需与雇主确认是否接受独立合同(Contractor)形式合作。
关于本页中文:职位描述由本机离线模型翻译,属机器翻译,供快速判断用;正式沟通与投递请以英文原文为准。官方翻译通道恢复后会自动重译升级。

我们团队成员是我们所做的一切的核心。在 Cencora,我们团结一致地负责创造更健康的未来,每个人都很重要要使我们能够实现这一目标。如果你想在卫生中心做出改变,请加入我们的创新公司并帮助我们改善人们和动物的生活。今天申请!工作详细 这一职位是在支持 Cencora 患者和提供商支持和药品商业化服务在加拿大通过我们的 Innomar 战略业务销售。责任:· 接收,扫描和记录所有相关临床信息符合 SOP/协议和适用的法律 ·与内部和外部客户直接合作,要求必要的附加信息或澄清;· 审查源数据文件 (包括访问报告/PIR 审查)和根据客户需求进行排序不利事件信息和产品质量投诉;· 将有害事件信息和生产品质性投诉数据输入和提交到特定方案的数据库中;· 分类和填写接入文件;·按照工作说明指示执行对不良事件的报告的质量检查。·协助并/或进行来源数据验证检查。· 准备调和 (每周,月刊等)报告 · 转录,翻译和编辑活动 · 准订并进行要求的后续信件和数据澄清 · 协助与参与不符合/CAPA 进程 · 药品安全副会员将偶尔被分配其他职责和任务。教育 · 最低水平大学教育所需。具有生命科学专业学位或学位是强大资产;工作经验:在医疗信息,临床研究或药物安全领域有1到3年的经验或类似及相关经验;· 医疗监督行业知识,包括最新的知识;加拿大卫生部,美国 FDA,EMEA 和 ICH 的药品监督指导方针;·适应变化和学习新技能如需;· 在医学和/或制药领域的经验 (),医疗术语是资产;·双语,英语/法语是资本。技能与知识 ·强大的分析能力 · 口头和书面有效沟通的能力。

查看英文原文

Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

This role is in support of Cencora’s patient and provider support and pharma commercialization services in Canada marketed through our Innomar Strategies business.
Responsibilities:

  • Receive, scan and document all pertinent clinical information in compliance with SOP/protocol and applicable legislation
  • Work directly with internal and external clients to request additional information or clarification as necessary;
  • Review of source data documents (includes visit report/PIR review) and triaging adverse event information and product quality complaints as per client needs;
  • Data entry and submission of adverse event information and product quality complaints into program specific databases;
  • Sorting and filing of incoming documents;
  • Perform quality check on adverse event reports as directed by the work instructions.
  • Assist with and/or perform source data verification checks
  • Screening medical and scientific literature for safety information
  • Preparation of Reconciliation (weekly, monthly etc.) Reports
  • Transcription, translations and redaction activities
  • Preparation and conducting solicited follow-up letters and data clarifications
  • Assist and participate in the non-conformance/CAPA process
  • The Drug Safety Associate will also be assigned other duties and tasks as required from time to time.

Education
· Minimum college level education required. A diploma or degree with a concentration in Life Sciences is a strong asset;

Work Experience:

  • 1-3 years experience in Medical Information, Clinical Research or Drug Safety or equivalent and related experience in pharmacy or pharmaceutical fields;
  • Knowledge of Pharmacovigilance industry including up to date knowledge of; pharmacovigilance guidelines of Health Canada, US FDA, EMEA and ICH;
  • Adaptability to change and to learn new skills as required;
  • Experience in the medical and/or pharmaceutical field(s), medical terminology is an asset;
  • Bilingual, English/French is an asset.

Skills & Knowledge

  • Strong analytical skills
  • Ability to communicate effectively both orally and in writing.
  • Effective interpersonal skills.
  • Effective organizational skills; ability to multitask.
  • Superior, proven attention to detail.
  • Ability to consistently meet deadlines.
  • Excellent problem-solving skills; ability to communicate and/or resolve issues effectively and efficiently
  • Computer skills (including knowledge of Microsoft Word, Excel, PowerPoint and other Office Programs)
  • Good internet required for remote work.

What Cencora offers
We provide compensation, benefits, and resources that enable a highly inclusive culture and support our team members’ ability to live with purpose every day. In addition to traditional offerings like medical, dental, and vision care, we also provide a comprehensive suite of benefits that focus on the physical, emotional, financial, and social aspects of wellness. This encompasses support for working families, which may include backup dependent care, adoption assistance, infertility coverage, family building support, behavioral health solutions, paid parental leave, and paid caregiver leave. To encourage your personal growth, we also offer a variety of training programs, professional development resources, and opportunities to participate in mentorship programs, employee resource groups, volunteer activities, and much more.
Full timeEqual Employment Opportunity
Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.
The company’s continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.
Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned
Accessibility Policy
Cencora is committed to fair and accessible employment practices. When requested, Cencora will accommodate people with disabilities during the recruitment, assessment and hiring processes and during employment.
Affiliated Companies:
Affiliated Companies: Innomar StrategiesOriginally posted on Himalayas

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