職位描述
藥品警戒臨床試驗安全臨床數據整理不良事件臨床研究
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 S
The responsibilities of the Senior/Drug Safety Associate may include, but are not limited to:
1.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)
2.Liaise with the investigational site and or reporter regarding safety issue.
3.Ensure accurate entry of safety data into the safety database or relevant system.
4.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.
5.Communicate with relevant stakeholder (Health Authority, Site Staff) to clarify enquiry of entered data on the safety database
6.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.
7.May assist the team member with safety case monitoring/ Screening activity on safety database.
8.May attend the project team meeting and teleconference as needed.
The responsibilities of the Senior/Drug Safety Associate may include, but are not limited to:
1.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)
2.Liaise with the investigational site and or reporter regarding safety issue.
3.Ensure accurate entry of safety data into the safety database or relevant system.
4.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.
5.Communicate with relevant stakeholder (Health Authority, Site Staff) to clarify enquiry of entered data on the safety database
6.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.
7.May assist the team member with safety case monitoring/ Screening activity on safety database.
8.May attend the project team meeting and teleconference as needed.
C O M P E T E N C I E S
1.Number, Timeliness and quality oof deliverable according to established directives
2.Compliance with internal and external regulations and SOPs.
1.Number, Timeliness and quality oof deliverable according to established directives
2.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 *** T S
QUALIFICATIONS
? 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 or
related Global/Regional experience
QUALIFICATIONS
? 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 or
related Global/Regional 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
? 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
工作地點
上海黃浦區人民廣場(地鐵站)
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職位發布者
郭玉玲/人事經理
立即溝通
愛恩康臨床醫學研究(北京)有限公司At ICON we believe that our people are the most important asset. It is they who have helped to make ICON the success it is. Their commitment to clients, quality and delivery has earned ICON its enviable reputation. About DOCS: DOCS- ICON Resourcing Solutions is a division of ICON plc that provides global staffing solutions to Pharmaceutical, Biotechnology, Medical Device companies and CROs in over 39 countries. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. ICON has been in APAC since 1996 and the DOCS division of ICON is now expanding in the APAC region. Our Services: We are a specialist recruitment division focusing in Clinical Research, Medical Affairs, Regulatory Affairs, Drug Safety, Health Economics, Data Management& Statistics, Quality Assurance etc. Our full-spectrum resourcing solutions extend from contingent staffing, to functional resourcing, large-scale FSP and executive search. In addition, DOCS has developed a tailored training division‘CRAcademy’ to provide Traineeships and Training. We can recruit in virtually any location having access to offices in over 25 countries. This truly makes DOCS a company with global reach and personal focus. Our History: DOCS was formed in The Netherlands in 1997 and grew to become the premier resourcing provider to the European pharmaceutical industry. The company was acquired by ICON plc in 2007 and was merged with ICON’s existing resourcing division, ICON Contracting Solutions. The merged company is now known as DOCS, and offers clients over 15 years of experience in the provision of global resourcing solutions. For more information, please visit www.docsglobal.com& www.iconplc.com.
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