藥物安全專員 上海復宏漢霖生物技術股份有限公司 上海復宏漢霖生物技術股份有限公司,復宏漢霖,復宏漢霖 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 flexible working attitude
Effective presentation and report writing skills
Effective team building skills
Effective telephone etiquette skills
Excellent 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 experience.
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 flexible working attitude
Effective presentation and report writing skills
Effective team building skills
Effective telephone etiquette skills
Excellent 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 experience.
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