岗位职责:
1.Effectively represent local PV team on relevant working teams as China clinical study team and submission team, providing the safety leadership and serving as the primary point of contact for both Global and China local studies.
2.Proactively communicate with global/local relevant functions (e.g. Clinical, RA, BDM) and provide the insight of safety information with China study team for product development and BLA/NDA submission in China.
3.Collaborate with study team at China clinical development providing safety inputs to support the local clinical trial, such as reviewing study related documents etc.
4.Effectively lead and manage available resources in developing/reviewing safety related documents to deliver high-quality ones for China IND/NDA, such as local RMP, etc.
5.Provide the pharmacovigilance interactions with internal and external stakeholders including alliance partner.
6.Provide scientific inputs from PV perspective in other activities to support drug development in China, such as pre-IND, pre-NDA meeting etc.
资历要求:
1、Clinical medical related background with master degree or above
2、At least 5 years relevant pharmaceutical industry experience of safety physician
3、Advanced knowledge of national and international regulations for pharmacovigilance
4、Good interpersonal skills and multitasks management ability
5、Good personalities with team spirit
6、Good leadership and spirit of ownership
7、Fluent in both written and spoken English