Act as the deputy of the Local Qualified Person for Pharmacovigilance in Novartis Country Organization to fulfill medical safety oversight and provide safety deliverables for assigned therapeutic areas/ products in China in full drug life-cycles.

Major accountabilities:

•Act as Qualified Delegate of the Country Patient Safety Head, functionally (in terms of responsibility for PV system) for assigned therapeutic areas/ products.

•Ensure robust oversight and compliance in terms of reporting/submission/distribution of safety reports/updates/information (e.g., SAE, SR, IN, SUSAR, PSUR, DSUR, changes in risk-benefit profile) to Local Health Authorities according to regulatory requirements and Novartis procedures.

•Provide medical safety support, including safety deliverables in CTA/ (s)NDA/ License Renewal/ Reimbursement dossier is done according to the timeliness described into the respective procedures or as committed with line functions. Play a joint role with global safety leads for safety relevant issues or requests.

•Represent PS in CTT for Post Approval Commitment (PAC) studies and China bridging clinical trials, with the support by global safety lead if needed.

•Work in close collaboration with other local and global medical safety functions to ensure accurate evaluation of safety data.

•Lead local RMP and RMP China addendum creation and approval, based on local regulatory or LHA requirement, if applicable.

•Conduct local safety signal detection and escalate to global medical safety for potential safety signals identified from all local post-marketing sources per local regulatory requirements.

•Provide scientific expertise during review of all Phase IV Clinical Trial and NIS protocols safety sections including Research Collaborations and if a Contract Research Organization (CRO) is conducting the trial or study, review safety relevant sections of the contract.

•Responsible for responses to inquiries from LHA on safety issues related, involve in the communication on safety topics related to responsible products with the LHA.

•Ensure support for and close-out of audits, corrective action plan, investigation, and Health Authority inspections.

Essential Requirements:

•Medical background

•At least 3 years experience in pharmacovigilance or equivalent field, or at least 2 year safety physician experience.

•Project management skills

Desirable Requirements:

•Excellent communications and negotiation (networking) skills

•Quality and results oriented

•Business mindset

为什么选择诺华：帮助患者及家属不仅需要创新科学，还需要一支包括你我他在内的充满智慧与激情的团队，大家相互协作、支持与激励。共同实现突破，改变患者的生活。一起共创更好的未来，你准备好了吗？

加入我们的诺华网络：这不是您心仪的职位？欢迎加入诺华人才社区，与我们保持联系，及时了解合适的职业机会。您也可以关注诺华集团招聘微信公众号及诺华集团招聘微信视频号。

薪酬与福利：您可以前往诺华官网了解我们帮助您实现个人与职业发展的举措。

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up. You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.

Benefits and Rewards: Go to Novartis career website to learn about all the ways we’ll help you thrive personally and professionally.

Databases

Safety Science

Pharmacovigilance

Employee Training

Reporting

Waterfall Model