1.博士学位,专业方向包括:(药物)流行病学、卫生/药物经济学、循证医学、公共卫生、临床药学或相关领域;
2.具备独立设计与执行真实世界研究项目经验,熟悉回顾性队列、前瞻性观察性研究、登记研究等方法;
3.熟练掌握至少一种数据分析工具(R/Stata/SAS/Python),能处理医保、电子病历、随访等多源数据;
4.优秀的中英文写作能力,能撰写符合国际国内主要监管机构要求及国际期刊标准的研究方案与报告;
5.深刻理解中国真实世界证据(RWE)监管路径,熟悉相关核心政策文件;
6.具有创新药械真实世界研究项目经验;熟悉医药产品综合价值评估框架,参与过卫生技术评估(HTA)或医保支付相关研究;具备与药监、医保、卫健等政府部门沟通协作等经验者优先。
Requirements:
1. PhD in Pharmacoepidemiology, Health Economics/Pharmacoeconomics, Evidence-based Medicine, Public Health, Clinical Pharmacy, or related fields;
2. Demonstrated experience in independently designing and conducting real-world studies (including retrospective cohorts studies, prospective observational studies, registry studies);
3. Proficiency in at least one analytical tool (R/Stata/SAS/Python) with the ability to manage and analyze multi-source data such as health insurance claims, electronic medical records, and follow-up datasets.;
4. Excellent Chinese and English scientific writing skills, with the ability to prepare study protocols and reports that meet the requirements of major national/international regulatory agencies and international journals.;
5. In-depth understanding of China’s regulatory pathways for real-world evidence (RWE) and familiarity with key related policy documents;
6. Experience in RWS of innovative pharmaceuticals or medical devices is preferred. Familiarity with comprehensive value assessment frameworks for medical products and prior involvement in HTA or healthcare reimbursement research is advantageous. Experience collaborating with government agencies such as drug regulatory authorities, healthcare security administrations, or health commissions is preferred.
1.主导针对创新药品与医疗器械的真实世界研究(RWS),涵盖患者报告结局(PROs)、安全性监测、有效性验证及卫生经济学评价;
2. 联合医疗机构与药企申办方,推动研究者发起或申办方发起的RWS项目落地,符合监管要求;
3. 承担医药产品综合价值评估工作,支撑医保目录调整、支付标准制定等政策决策;
4. 撰写高质量证据报告,服务于国家及地方卫生技术评估与医保准入;
5.其他领导交办的任务。
Key Responsibilities:
1.Lead real world studies (RWS) for innovative pharmaceuticals and medical devices, covering patient-reported outcomes (PROs), safety surveillance, effectiveness validation, and health economic evaluation;
2.Collaborate with healthcare institutions and pharmaceutical sponsors to implement investigator-initiated or sponsor-initiated RWS projects in compliance with regulatory requirements;
3.Conduct comprehensive value assessments of medical products to support national reimbursement catalog updates and payment standard setting;
4.Produce high-quality evidence reports to support national and regional health technology assessment (HTA) and reimbursement access decisions;
5.Fulfill other tasks assigned by senior leadership.
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