职位

1. Support in LSR in establishing and maintain a local PV system in context
with and as defined in the wider global Roche PV system. In addition, ensure
adequate PV associated quality system are in place in collaboration with the
LQR.

* Ensure appropriate process are in place, including qualification and
training of staff involved.
* Establish and maintain quality processes to ensure ongoing oversight of the
performance of the PV system through fit for purpose local self-organized
teams. This also includes proactive identification of actual or potential
developing PV compliance concerns, ensuring adequate action is taken in a
timely manner, and informing or escalating to local senior management and/or
the PVCCL, as applicable.
* Ensure appropriate documentation of PV related information and activities.
* Ensure business continuity of critical PV systems, processes, and
activities.
* Ensure continual monitoring of local PV regulations, perform impact
assessments of amended or new PV
* regulations, and ensure new PV requirements are implemented effectively and
in a timely manner.
2. Pharmacovigilance System Master File (PSMF)

* Ensure the data included in local PSMF is current, accurate, complete, and
provided in a timely manner.
* Establish and maintain local PSMF process and ensure consistency with
global Roche processes.
3. Act as local Drug Safety Committee (DSC) coordinator to support the
relevant local DSC activities

* As the point of contact for local DSC, receive and review the meeting
requests, coordinate the topics to discuss for each DSC meeting.
* Ensure the actions triggered by local DSC discussions are well tracked
and/or escalated to global DSC for further discussion and assessment if
applicable.
4. Partnering and Enablement - "Safety Business Partnership (SBP)"

* Support LSR in leading the Local Safety Unit (LSU) to be the Safety
Business Partners in the affiliates both internally and externally.
* Understand the wider affiliate objectives and drive the partnership with
affiliate and global functions to advance the impact and contributions of PV in
the local context.
* Support LSR in driving continuous improvement of local safety capabilities
in operational PV and safetyscience expertise, including the ability to apply
safety science insights in the local context. Among others,this may include
activities to enhance the safe use of Roche medicinal products, treatment
outcomes,patient experience, effective safety communication, fit for purpose
risk minimization, product launchsupport, product access, and generation of
additional safety insights.
5. Support LSR in Other Team Activities

* Bachelors or Master Degree in healthcare related field (Health care
professional, i.e., Clinical medicine, Pharmacist, Nurse.) or in bioscience,
medical degree is preferred.
* Able to lead virtual team with non-direct report, good cross-functional
communication and project management skills.
* Relevant working experience: 4-5 years of experience in PV
* Language: Excellent written and spoken English and Chinese
* Knowledge on PV knowledge and relevant regulations (ICH, EMA, FDA, NMPA)
我们是谁


在罗氏，来自100个国家的100，000名员工不断推动着健康医疗行业的进步。我们一同工作，使罗氏成为了世界领先的以研发为基础的健康医疗集团。我们的成功源于创新、求知和多元化，也源于我们把相互间的差异作为一种优势。为了革新医疗健康领域，罗氏设定了远大的计划，坚持学习和发展，并不断寻找与之志同道合的伙伴。


罗氏中国由制药和诊断两大业务领域组成，员工总数超过7000人。作为全球个体化医疗的领导者，罗氏制药和罗氏诊断均在中国建成了完整的价值产业链，包括研究、开发、生产、营销等环节。未来，上海将成为罗氏继巴塞尔和旧金山之后的第三大全球战略中心，而罗氏也将继续践行对中国的长期承诺，满足中国患者的未尽之需。

罗氏提供平等的职业发展机会。