Pharmacovigilance Specialist (PVS) 上海

月薪： 1-1.5万/月

该公司所有职位
  • 1年经验
  • 本科
  • 招2人
  • 02-04 发布

职位描述

POSITION SUMMARY To responsible for timely reporting and processing of respective Serious Adverse Events (SAE), Adverse Event(AE) Serious and non-Serious Adverse Drug Reaction(SADR) and other medically related project information within agreed timeline to Health Authority and other Key Stakeholders. To responsible for document archiving, data tracking communication of respective safety reports in compliance with company’s and relevant regulator’s requirements. JOB FUNCTIONS/RESPONSIBILITYES The responsibilities of the (Senior) Pharmacovigilance Specialist 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 S/K 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 of 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 S/ QUALIFICATIONS Bachelor/Master or qualified in major of life science; 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 or Related Global/Regional CRO/ pharmaceutical industry working experience EXPERIENCE & 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： 临床数据分析员 关键字： PV Drug Safety 药物警戒 药物安全

联系方式

黄陂南路838弄

公司信息

PPC佳生（Protech PharmaservicesCorporation）成立于1997年，致力于为国内外制药企业及生物技术公司提供专业化临床研究服务，为中国大陆、中国台湾、韩国以及日本等亚太地区客户提供临床试验及生物样本检测分析服务。自1997年至今，自成立以来，PPC佳生已为来自全球范围客户完成了2000多个早期临床研究项目（包含新药I期PK、仿制药BA/BE以及生物类似药PK/PD）；并且还执行了超过400个新药后期临床试验项目；所执行的研究方案涵盖24个疾病治疗领域。目前是亚太区域唯一通过日本PMDA、欧盟ANSM、东盟NCPB以及美国FDA核查的临床基地，生物样品实验室开发约300种药品分析方法，以丰富的执行经验提供海内外客户优质服务。2012年，PPC佳生于台北（McKay memorial Hospital）建立了第一家下属I期临床试验中心，并于2016年作为主要投资方与徐州医科大学资源共享，优势互补联合组建合作共同建立了徐州医科大学附属医院I期药物临床试验中心。

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