Drug Safety Associate/Pharmacovigilance Specialist招聘_爱恩康临床医学研究（北京）有限公司最新招聘信息-猎才医药网

Drug Safety Associate/Pharmacovigilance Specialist 上海

爱恩康临床医学研究（北京）有限公司

月薪： 6-8千/月

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