上海招聘

Responsible for:
Support and collaborate with business partners to develop ASR prepared by partners to ensure submission compliance within BeiGene’s territories.
Coordinate regional appendices preparation with applicable contributors and provide regulatory guidance.
Support and coordinate local translation process as needed.
Review ASR-related documents, including but not limited to the Pharmacovigilance Agreement (PVA), Pharmacovigilance Safety Master File (PSMF), Safety Management Plan (SMP), Safety Reporting Plan (SRP).
Leading critical process or sub-process areas as well as project initiatives within GPS organization or as GPS representative to other functions
Assist in the development of department-specific SOPs and Work Instructions.
Support internal and external GPS department trial audits or inspections.
Assist the line manager to participate in other department projects as needed.
Act as the backup of ASR Lead
Oversees all ASR end-to-end processes, including but not limited to the below activities:
Review BeiGene Aggregate Safety Report Schedule to ensure all information is accurate and complete and notify vendor of any ad hoc or requested reports.
Monitor and review the Expedited and Periodic Safety Reporting Plan (ESRP) to ensure all the information is complete and accurate, the local requirements are captured and up-to-date.
Attend regular meetings with the vendor to review upcoming ASRs, go through ongoing ASR progress, and discuss and resolve any outstanding issues.
Monitor the preparation schedule to ensure all steps follow the schedule and escalate any potential risks.
Review the submission tracker, submission evidence, and compliance report to check submission compliance.
Discuss and confirm reporting requirements for the new submission destination.
Identify and review relevant QE and CAPA to improve and optimize processes.
Check the qualification of vendor team members (e.g., CV, JD, training record).
Check KPI, quality, and risk indicators.
Essential Functions of the job:
Execute the coordination, authoring, development, quality control of aggregate safety reports (e.g. DSUR, PBRER, PADER) in partnership with safety science and Product Safety Lead
Liaise with contributing functions to ensure timely and publication ready content
Ensure completion of ASR in timely fashion for global submissions through partnering functions or third party vendors
Performance Metrics
Responsible for the definition and generation of metrics addressing internal timeline &
work in progress performance
Manage the root cause analysis of issues revealed by review of metrics
Responsible for the definition and generation of metrics addressing work volumes
Responsible for the determination of actions stemming from metrics review
Continuous Improvement, Compliance, Standards and training
Manage continuous improvement opportunities within ASR management
Ensuring inspection readiness
Develop and monitor compliance targets and their ongoing determination
Vendor Oversight
Oversee Training, oversight monitoring, performance metrics review of vendor activities where applicable
May lead and/or participate as ASR subject matter expert (SME) on cross functional projects as needed
Decision Making Authority:
In process management decisions consistent with operational policies, SOPs and WIs
Contribute to Operational policies, SOPs and WIs
Contribute to Staff recruitment
Outputs
Process metrics
Consistent process practices
Process timelines consistent with regulatory compliance
Key Relationships:
Safety OPS, Safety Records and Submissions, Clinical OPS, Medical Review Physician, Product Safety Leads, Safety Physicians and Scientists, Product Quality, Safety Systems Team
Qualification Required:
Knowledge/Experience
Strong understanding of Global regulatory requirements (i.e. ICH, GVP, FDA 21CFR312.32, 314.80, GCP, NMPA Announcement (No. 66, 2018), PAL of PRC (Dec 2019)) for capture and submissions of pharmacovigilance individual case safety reports and aggregate safety reports to FDA, CDE/NMPA, EMA, MHRA, and other global regulatory authorities/national competent authorities
Clinical knowledge of therapeutic area patient populations and drug class
Aggregate Safety Report development or coordination experience.
Adapt in development and monitoring of key performance indicators, compliance and quality metrics
Thorough appreciation of the utilization of aggregate safety data and the representation of ICSRs in aggregate safety reports
Experience in effective project management strategies for high quality and on-time delivery of cross functional projects
Ability to oversee team deliverables and to represent functional responsibilities in audits and inspections
职能类别：
药物警戒经理
关键字：
ASRPVSafety

百济神州是一家植根中国的全球性商业化生物医药公司，致力于成为分子靶向药物和免疫肿瘤药物研发，及商业创新领域的全球领导者。
2017年，百济神州与新基公司达成战略合作伙伴关系，向新基转让了tislelizumab在美国、欧洲、日本和亚洲以外的其他地区的实体瘤开发和商业化的独家权益，保留了在亚洲（除日本外）开发和商业化tislelizumab用于治疗实体瘤的权益，以及用于治疗恶性血液肿瘤和进行内部组合疗法的全球范围权益。

此外，百济神州获得了新基公司在华获批药物——注射用白蛋白紫杉醇（ABRAXANE？）, 瑞复美（REVLIMID？）和 维达莎（VIDAZA？）的独家授权，并接管其在华商业运营团队。

2018年1月，百济与Mirati公司sitravatinib在亚太地区的独家授权协议，进一步拓宽了公司的产品组合。

截至目前，百济神州在全球各地拥有超过1100名员工，其中包括在中国、美国、澳大利亚和瑞士的超过650名科学家及临床医学专家。

公司在中国的北京、上海、美国的马萨诸塞州Cambridge，新泽西州Fort Lee和加利福尼亚州旧金山Emeryville和San Mateo，瑞士的巴塞尔均设有办事机构。除此之外，百济神州在中国大陆还拥有位于北京的研发中心，苏州、广州两大生产基地，以及在上海的商业运营中心。