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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, Therapeu??c Area and Disease Pathway knowledge suppor??ng the needs of local Medical Affairs/Marke??ng organiza??on and R&D organiza??on in collabora??on with the Interna??onal Medical Safety leader. Act as safety expert in local cross-func??onal team mee??ngs for discussion and evalua??on of topics related to benefit risk and product safety.
2、Develop/maintain local RMPs for responsible products.
3、Support the implementa??on of RMPs and Urgent Safety Restric??ons (USR), if required.
4、Be involved in R&D ac??vi??es to support the safety inputs for the NDA/BLA submission package.
5、Work together with regulatory colleagues to maintain and update the safety informa??on in local label by referring to CCDS, USPI/SmPC, etc. Take appropriate measures to ensure that new safety informa??on is available to HA and Healthcare Professionals (HCPs) in a ??mely manner, i.e., Direct Healthcare Professional Communica??on (DHPC), company core datasheet (CCDS) implementa??on into local label, USR if applicable.
6、Provide medical input and insights for aggregate reports and submit the safety aggregate reports to China Health Authori??es.
7、Develop local safety summary report to support product license renew in China or per ad hoc requests.
8、Provide input into safety sec??ons of local protocols (including Clinical Trials, Non-Interven??onal Studies, RRAs, PSPs etc.) to ensure appropriate safety repor??ng as required by regula??ons. Perform concept and protocol review related to data genera??on ac??vi??es - clinical and post-authoriza??on studies and local Safety Monitoring Plan.