Responsibilities:
Managing Local Medical Safety activities to ensure proactive Benefit Risk Management throughout product life cycle translating global safety data to insights and actions tailoring to local specificities and needs, including taking PV activities for post-marketing products and also providing medical safety support to R&D activities for in-development compounds, covering multiple Therapeutic Area (TAs), i.e. Immunology, Neuroscience, Cardiopulmonary, Established Products, etc.
With Key activities as below:
1.Establish Product knowledge with focus on safety profiles, Therapeutic Area and Disease Pathway knowledge supporting the needs of local Medical Affairs/Marketing organization and R&D organization in collaboration with the International Medical Safety leader. Act as safety expert in local cross-functional team meetings for discussion and evaluation of topics related to benefit risk and product safety.
2.Develop/maintain local RMPs for responsible products.
3.Support the implementation of RMPs and Urgent Safety Restrictions (USR), if required.
4.Be involved in R&D activities to support the safety inputs for the NDA/BLA submission package.
5.Work together with regulatory colleagues to maintain and update the safety information in local label by referring to CCDS, USPI/SmPC, etc. Take appropriate measures to ensure that new safety information is available to HA and Healthcare Professionals (HCPs) in a timely manner, i.e., Direct Healthcare Professional Communication (DHPC), company core datasheet (CCDS) implementation into local label, USR if applicable.
6.Provide medical input and insights for aggregate reports and submit the safety aggregate reports to China Health Authorities.
7.Develop local safety summary report to support product license renew in China or per ad hoc requests.
8.Provide input into safety sections of local protocols (including Clinical Trials, Non-Interventional Studies, RRAs, PSPs etc.) to ensure appropriate safety reporting as required by regulations. Perform concept and protocol review related to data generation activities - clinical and post-authorization studies and local Safety Monitoring Plan.02

Qualification
1.Sound knowledge of medicinal and clinical practice; proficiency in medical terminology (local languages).
2.Good verbal and written communication skills, fluency in local language(s) and English language required.
3.Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety.
4.Scientific study and experience in pharmaceutical regulations and R&D processes.
5.Pharmaceutical industry experience including a PV responsibility and PV Physician role required.