长沙招聘

Job Responsibilities:

Reviews all appropriate safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature).

Conducts medical assessment of all safety related data (AEs, SAE, SUSAR, Argus, etc.).

Ensures medical accuracy of case narratives, coding and medical sense of all cases and ensures appropriate queries are raised to expedite case closure.

Contribute to the development of safety part of clinical protocols.

Provide medical/scientific input into safety reports including China specific safety reports like product safety summary for license renewal, etc.

Writes safety section, including benefit risk assessment of aggregate safety reports such as Periodic Drug Safety Reports (PSURs), Periodic Adverse Drug Experience Reports (PADERs) for regulatory submission.

Contribute to the development and maintenance of Risk Management Plans (RMP) from the point of view of a medical safety expert if needed.

Contribute to the development and performance of China Intensive Drug Monitoring program.

Provides safety training to internal employees and external contractors as needed.

Participates in investigators’ meetings to provide training on adverse events reporting as required.

Education, Skills and Experience:

Bachelor of medicine.

2 or more years of relevant pharmaceutical or related experience (e.g. drug safety, clinical development, medical affairs)

Strong orientation towards cross-functional teamwork

Familiar with MedDRA and safety databases is preferred.

Good verbal and written English communication skills.

Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), e-mail, and internet

上海百试达医药科技有限公司是一家为国内外医疗机构，医药研究机构、专业协会、医药和医疗器材企业提供高质量临床研究服务、医学教育和科研服务的专业学术机构，同时也是国内领先的创新药物研发机构。公司临床研究服务、医学教育和科研服务分布在药品、医疗器械、生物制品、诊断试剂多个等领域，为客户提供专业化的技术解决方案和服务。创新药物研发与国内外医药研发机构有广泛的合作，致力于创新药物的国内临床开发。
上海百试达业务范围包括临床试验的设计、组织、运作和管理，如I-IV 期药物临床试验和医疗器械临床试验项目的策划和筹备、方案撰写、基地筛选、临床监查服务、药物管理、数据管理和生物统计、研究报告撰写。公司还提供药品和医疗器械注册和医学咨询和代理、流行病学观察性研究、医药市场研究和研究者、CRA 和其他临床研究专业人员的培训等。创新药物研发包括化合物和大分子生物制品的筛选，活性药物合成和制剂，化学药物和生物药品的国外专利技术的国内转化以及相应的临床开发。
上海百试达拥有资深的专业研究团队，主要研究人员均具有外资制药企业药物研发部和临床研究部工作经验。具有国际化、标准化的业务运作流程和科学严谨的质量保证体系，谙熟国际多中心临床试验和国内各种类型临床试验项目的运作和管理。此外，百试达还在临床医学，临床药理学和生物统计领域拥有一大批专家网络资源，并通过高质量的各类人员和项目培训不断扩大这一网络，从而保证各类临床项目的快速和高质量的完成。
公司的合作客户包括知名跨国制药公司和医疗器械企业、国内研发型制药企业、医药科研院所以及专业学术团体等。
公司总部位于上海，在北京、广州、成都、武汉设立分支机构，服务范围覆盖全国多个中心城市和区域；在美国波士顿设有联络处和QA 办公室。