天津招聘

Responsibilities

l 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.

l Create and maintain SAE reconciliation trackers for all internal studies.

l Maintain CMA safety database

l Identify issues and understand the causes of those issues independently. Report any lack of safety data management issues to Quality & Compliance team.

l Interfaces, collaborates, and negotiates with project members, and resolves issues with guidance as needed

l Ensure integrity and completeness of data according to applicable regulations and guidelines, SOPs and project-specific guidelines.

l Read and understand Safety Management Plan across each projects.

Work with Quality & Compliance department and participate CAPA meeting if it is required.

l In-depth knowledge of ICH-GCP, SOP, and local regulation. Especially familiar with safety data management within clinical trials.

Competences / Skills

l Working knowledge of AE/SAE management processing

l Working knowledge of applicable global, regional and local clinical research regulatory requirements

l In-depth knowledge of departmental SOPs and ICH-GCP

l Strong organizational skills with the ability to meet strict deadlines

l Skill in use of multiple safety databases

l Basic project management skills

l Demonstrate a positive and flexible working attitude

l Effective presentation and report writing skills

l Effective team building skills

l Effective telephone etiquette skills

l Excellent verbal and written communication skills

l Ability to work effectively on multiple projects simultaneously and effectively manage competing priorities

l Bachelor's degree from a four-year college or university in life sciences or related field.

l 1-3 years clinical research pharmaceutical, or CRO company, or related organization and/or an equivalent combination of education and experience.

    复宏汉霖（*******）是一家国际化的创新生物制药公司，旨在为全球患者提供质高价优的创新生物药，产品覆盖肿瘤、自身免疫性疾病等领域。自2010年成立以来，公司以全球联动、整合创新为产品开发理念，在中国上海、中国台北和美国加州均设有研发中心，具备了协同增效的突出优势。复宏汉霖主要的产品开发策略是仿创结合，从生物类似药起步，逐步开发创新型单抗产品，结合自主开发的抗PD-1和PD-L1单抗，在国内率先推出免疫联合疗法，前瞻性布局了一个多元化、创新单抗及肿瘤免疫联合疗法管线，打造出研究、开发、商业化生产的综合性生物医药全产业链平台。

    截至目前，复宏汉霖已有1个产品成功上市，2个产品获得中国新药上市申请受理，1个产品获得欧盟营销授权申请受理，10个产品、8个联合治疗方案在全球范围内开展20多项临床试验。其中，公司首款重磅产品汉利康？（利妥昔单抗注射液）于2019年2月获国家药监局新药上市注册批准，成为中国***获批上市的生物类似药。HLX03（阿达木单抗注射液）与HLX02（注射用曲妥珠单抗）已获国家药监局新药上市申请受理，现已纳入优先审评程序。HLX02相继在中国大陆、乌克兰、欧盟波兰和菲律宾全面启动国际多中心3期临床试验，成为国内***开展国际多中心3期临床研究的生物类似药，并于2019年6月获欧洲药品管理局营销授权申请受理。此外，公司已陆续就HLX10（抗PD-1单抗）与自有产品HLX04（贝伐珠单抗生物类似药）、HLX07（抗EGFR单抗）以及化疗联用开展多项肿瘤免疫联合疗法，在全球范围内开展多个临床研究。