- 目录
第1篇 药物安全岗位职责
药物安全 1、负责与医学部有关的临床试验不良事件(ae)及严重不良事件(sae)报告的医学评估及质量审核,并监督其报告与处理流程符合国家法律法规的要求及公司相关规定
2、 确保在规定的时限内按法规要求汇报个例安全报告给有关卫生监管机构
3、 负责准备及制作产品定期安全性更新报告(psur)及不定期的特别报告;
4、维护与更新公司药物警戒相关工作流程及规范,如标准操作规程(sop)、工作指南、药物安全系统操作指南等;
5、给予医学部内部及公司其他相关部门提供药物安全性工作支持;
6、维护公司安全性数据库的运行,确保与医学部有关的ae报告准确及时进入公司的安全性数据库,并符合数据库系统的要求
7、根据法规要求,进行药物信号管理、药物风险管理等工作;
8、根据需要,给项目组的成员包括监查部提供安全性内容的培训;
9、 参与监管机构的审查;
在制药企业或cro公司至少2年相关工作经验,具备药物警戒工作相关知识;
了解相关药物安全性监管要求,包括《药品管理法》、《新药审批办法》、ich-gcp
等;
1、负责与医学部有关的临床试验不良事件(ae)及严重不良事件(sae)报告的医学评估及质量审核,并监督其报告与处理流程符合国家法律法规的要求及公司相关规定
2、 确保在规定的时限内按法规要求汇报个例安全报告给有关卫生监管机构
3、 负责准备及制作产品定期安全性更新报告(psur)及不定期的特别报告;
4、维护与更新公司药物警戒相关工作流程及规范,如标准操作规程(sop)、工作指南、药物安全系统操作指南等;
5、给予医学部内部及公司其他相关部门提供药物安全性工作支持;
6、维护公司安全性数据库的运行,确保与医学部有关的ae报告准确及时进入公司的安全性数据库,并符合数据库系统的要求
7、根据法规要求,进行药物信号管理、药物风险管理等工作;
8、根据需要,给项目组的成员包括监查部提供安全性内容的培训;
9、 参与监管机构的审查;
第2篇 外资医药集团患者支持专员（药物安全）岗位职责职位要求
职责描述：
key accountabilities：
program implementation
collaborating with charity organizations to supervise psp program operation;
forecast of donation goods to prevent disruption of donation supply and support biz team requirement of program enrollment， return rate， ongoing pool， or any specific projection;
pdcs/drug safety supervision over the ongoing programs to ensure pv compliant;
support cdi/nrdl/prdl listing efforts， in terms of dossier， analysis or communication;
develop and deliver trainings/communication dossier， to internal (cross functions) and e_ternal stakeholders (physicians/nurses/drug dispensers/officials， etc.);
support with patient group activities， in terms of patient education， dossier preparation and site coordination.
scope of people responsibility：
support line manager and the team to achieve smooth operation ofpspprograms
candidate’s profile：
education
bachelor degree with industry related education preferred;
data process/analysis background being a plus;
fluent in english， both literal and oral
work e_perience：
2-year e_perience in pharmaceutical industry， with e_perience in leading pharmaceutical mnc being a plus
job-specific competencies & skills：
good interpersonal skills， with team-work spirit
good command of computer software， e_cel/powerpoint/word
responsible and result-oriented
地址：北京朝阳区将台路甲2号 诺金中心25楼（近地铁14号线望京南-地铁站）
附近公交：408路 416路 421路 571路 657路677路 682路 701路 847路 983路 运通104线运通107线 运通111线
岗位要求：
学历要求：本科
语言要求：不限
年龄要求：不限
工作年限：无工作经验
第3篇 药物安全专员岗位职责
药物安全专员 上海复宏汉霖生物技术股份有限公司 上海复宏汉霖生物技术股份有限公司,复宏汉霖,复宏汉霖 receive and document incoming reports from investigative sites or other sources reporting aes, serious adverse events (saes) and spontaneous events; collect, track required data and enter into safety database, if applicable; follow up with pms to obtain missing data as required.
create and maintain sae reconciliation trackers for all internal studies.
maintain cma safety database
identify issues and understand the causes of those issues independently. report any lack of safety data management issues to quality & compliance team.
interfaces, collaborates, and negotiates with project members, and resolves issues with guidance as needed
ensure integrity and completeness of data according to applicable regulations and guidelines, sops and project-specific guidelines.
read and understand safety management plan across each projects.
work with quality & compliance department and participate capa meeting if it is required.
in-depth knowledge of ich-gcp, sop, and local regulation. especially familiar with safety data management within clinical trials.
competences / skills
working knowledge of ae/sae management processing
working knowledge of applicable global, regional and local clinical research regulatory requirements
in-depth knowledge of departmental sops and ich-gcp
strong organizational skills with the ability to meet strict deadlines
skill in use of multiple safety databases
basic project management skills
demonstrate a positive and fle_ible working attitude
effective presentation and report writing skills
effective team building skills
effective telephone etiquette skills
e_cellent verbal and written communication skills
ability to work effectively on multiple projects simultaneously and effectively manage competing priorities
bachelor's degree from a four-year college or university in life sciences or related field.
1-3 years clinical research pharmaceutical, or cro company, or related organization and/or an equivalent combination of education and e_perience.
