职位描述
药品警戒临床试验安全临床数据整理不良事件临床研究
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
