Drug Safety Associate/Pharmacovigilance Specialist 上海

月薪： 6-8千/月

该公司所有职位
  • 1年经验
  • 本科
  • 招2人
  • 02-24 发布
  • 五险一金
  • 补充医疗保险
  • 交通补贴
  • 餐饮补贴
  • 专业培训
  • 年终奖金
  • 弹性工作
  • 定期体检

职位描述

J O B F U N C T I O N S / R E S P O N S I B I L I T I E SThe responsibilities of the Senior/Drug Safety Associate may include, but are not limited to:? Perform initial review of the adverse event perform seriousness and relatedness assessment and follow up SAE/AE/ADR/SADR queries to investigator sites or reporter(s)? Liaise with the investigational site and or reporter regarding safety issue.? Ensure accurate entry of safety data into the safety database or relevant system.? May assist the team in create patient adverse event narratives, if appropriate? Archive document related to entered safety data and other in accordance with regulatory requirement, respective SOPs and manuals.? Communicate with relevant stakeholder (Health Authority, Site Staff) to clarify enquiry of entered data on the safety database? May assist the Medical team to train member from other department on how to collect safety information for Spontaneous safety reporting of marketed product to the company.? May assist the team member with safety case monitoring/ Screening activity on safety database.? May attend the project team meeting and teleconference as needed. C O M P E T E N C I E SK E Y P E R F O R M AN C E I N D I C AT O R S? Number, Timeliness and quality oof deliverable according to established directives? Compliance with internal and external regulations and SOPs.E D U C A T I O N , E X P E R I E N C E , S K I L L S AN D K N O W L E D G E R E Q U I R E M E N T SQUALIFICATIONS? BA/BS/BSc or qualified nurse (RN);? Medical / Science background with relevant clinical experience? Knowledge of medical Terminology? Excellent communication skill? Senior Drug Safety Associate - min 3 years’ experience as Drug Safety Associate orrelated Global/Regional experienceEXPERIENCE & SKILLS? Work experience in life sciences or medically related field, including biopharmaceutical clinical research experience obtained working on clinical trials in a biotech, pharmaceutical or CRO company 职能类别： 医药技术研发管理人员 临床数据分析员 关键字： 周末双休 带薪年假 五险一金 年终双薪 人才推荐奖 交通补助 节日福利 专业培训 补充医疗保险

联系方式

南京西路288号创兴金融中心

公司信息

ICON Clinical Research-- a top global CRO company. For more details, please kindly see our website - http://www.iconplc.com/

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