广州招聘

Job Description

岗位职责：

1、 Effectively manages the drug safety function to ensure that safety reports received from clinical trials (and post-marketing) are processed and reported according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures.

负责管理药品安全，确保从临床试验中(以及上市后)收到的安全报告严格按照ICH-GCP指南、监管要求和公司的SOP和程序进行处理和报告。

2、 Provides medical expertise in the review and analysis of clinical study safety information.

运用临床知识及经验对临床试验中出现的药物安全问题做出正确评估与处理。

3、 Participates in the review of individual SAE reports, prepares medical commentary and analysis, and in the preparation of safety evaluations in aggregate periodic reports. Coordinate with other relevant departments to complete the required reports of various pharmacovigilance (DSUR/PSUR, PBRER, RMP, etc.);

参与SAE报告的审查，进行医学分析，并在定期汇总报告中作出安全评价。协同其它相关部门完成各类药物警戒所需报告(DSUR/PSUR, PBRER, RMP, etc.).

4、 Represents the Pharmacovigilance & Drug Safety department in safety-related discussions with clinical investigators and regulatory authorities.

代表药物警戒和药物安全部门与临床研究者和监管机构进行药物安全相关的讨论。

5、 Prepares and maintains PV policies and SOPs.

负责制定和实施PV管理制度及SOP。

6、Provide regulatory basis by continuously studying laws and regulations and guidelines in China, the United States, Europe, ICH, etc.

通过持续关注和研读中、美、欧、ICH等相关法规、指南，为公司注册申报提供法规依据。

Qualifications

任职要求：

1、In-depth theoretical knowledge in pharmacovigilance and regulatory affairs, strong problem-solving skills in tox field and experience with pharmacovigilance in global development of unlisted drugs.

深刻的药物警戒和药物注册专业知识和解决问题的能力，有未上市药物全球研发的药物警戒经验。

2、M.S. with 5+years relevant working experiences in biotech or big pharma. Conditions may be relaxed as appropriate for medical specialty.

硕士学历5年以上在生物制药企业或大型药企的相关领域工作经验。医学专业可适当放宽条件。

3、Familiar with domestic pharmaceutical industry development frontier information, including relevant policies and regulations, cutting-edge technology and other professional knowledges.

熟悉国内制药行业发展前沿信息，包括相关政策法规、前沿技术等专业知识；

4、Good communication and technical writing skills in both Chinese and English. Capable of engaging in scientific dialog among large groups of scientists, senior management, and external scientific experts.

优秀的中英文沟通和写作能力，能与科学家团体、高级管理人员和外部科学专家自如交流。

    安济盛生物医药技术（广州）有限公司地处广州科学城，是一家专注于骨骼肌肉关节等疾病的创新药物研发企业。安济盛生物医药技术（广州）有限公司的创始人及核心团队拥有多年在海外及国内大型跨国公司的药物研发和管理经验。公司拥有专业技能的新药靶标的研发团队，精通骨科疾病的病理生理学，运用遗传学和分子生物学前沿科学发现新的机理和信号传导通路及之间的互相作用，识别新的药物靶点，结合计算机辅助设计新型生物药物和小分子药物。公司产品的开发模式包括内部研发、与学术单位和全球业界研究机构建立外部合作等，服务于有需要的患者。欢迎有专业技能、积极乐观、上进和有团队合作精神的人士加入我们的团队。
我们的使命: 致力研发突破性创新药物，造福重症肌肉骨骼疾病患者！
Located in Guangzhou Science City, Angitia Biopharmaceuticals is an innovative biotech focusing on the discovery and development of novel drugs for serious bone, muscle and joint diseases. The founder and the core team members of Angitia are seasoned scientific leaders in new drug discovery, development and management from both overseas and domestic large multinational companies. The company has built an organization distinguished by world-class scientists with talents that proficient in the pathophysiology of musculoskeletal diseases. We utilize cutting-edge technologies of genetics and molecular biology to uncover new mechanisms, signal transduction pathways and their interactions combined with computer aided drug design to identify new drug targets, and to discover and develop new biological and small molecule medicines.？ The company is committed to serving patients in need by carrying out innovative science includes internal research and external collaborations with academics and global biopharmaceutical companies. We are seeking people who are competent, ambitious and great team players to join our vibrant group.
Our mission is to discover, develop and commercialize breakthrough therapeutics that address the key unmet medical needs of serious musculoskeletal diseases.