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PV Physician（8months temp）
35-42K/月北京市-北京/硕士及以上/5-10年
宋法纪一周前来过
北京汇才一品管理咨询有限公司
职位详情
岗位职责
任职要求：
Qualification
Essential Knowledge & Skills
• Sound knowledge of medicinal and clinical practice; proficiency in medical terminology (local languages).
• Good verbal and written communication skills, fluency in local language(s) and English language required.
• Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety.
Experience
• Scientific study and experience in pharmaceutical regulations and R&D processes.
• Pharmaceutical industry experience including a PV responsibility and PV Physician role required.
岗位职责：
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:
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.
Develop/maintain local RMPs for responsible products.
Support the implementation of RMPs and Urgent Safety Restrictions (USR), if required.
Be involved in R&D activities to support the safety inputs for the NDA/BLA submission package.
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.
Provide medical input and insights for aggregate reports and submit the safety aggregate reports to China Health Authorities.
Develop local safety summary report to support product license renew in China or per ad hoc requests.
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.
Qualification
Essential Knowledge & Skills
• Sound knowledge of medicinal and clinical practice; proficiency in medical terminology (local languages).
• Good verbal and written communication skills, fluency in local language(s) and English language required.
• Demonstrable knowledge of all local PV requirements and of Global aspects of drug safety.
Experience
• Scientific study and experience in pharmaceutical regulations and R&D processes.
• Pharmaceutical industry experience including a PV responsibility and PV Physician role required.
岗位职责：
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:
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.
Develop/maintain local RMPs for responsible products.
Support the implementation of RMPs and Urgent Safety Restrictions (USR), if required.
Be involved in R&D activities to support the safety inputs for the NDA/BLA submission package.
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.
Provide medical input and insights for aggregate reports and submit the safety aggregate reports to China Health Authorities.
Develop local safety summary report to support product license renew in China or per ad hoc requests.
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.
任职要求
无
工作地点
- 华贸
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公司信息
某医药公司
- 上海
- 10000人以上
- 生物技术
- 外企
- 不需要融资
强生公司诞生于1886年，经过130多年的发展，如今我们已经是全球最具综合性、业务分布范围广的医疗健康企业之一，业务领域覆盖制药、医疗科技，以及消费者健康领域，在全球约60个国家或地区已经拥有约260家运营公司，全球员工超过14万人。
1985年，强生来到了中国。大家熟知的西安杨森制药有限公司就是强生在华成立的第一家企业。多年来，我们一直致力于提供高质量的创新产品来满足不断增长的医疗健康需求，为中国病患和消费者带来健康，建设健康中国。如今，强生各大业务领域均已进入中国，并分别在该领域成为业界领头羊。2019年，强生中国创新引擎启动。对强生来说，中国不仅仅是重要的市场，也是重要的创新发展助推器。未来，我们将继续扎根中国、投资中国，以强生的百年信条为指引，融合关爱、科学与智慧，为人类健康事业的发展带来意义深远的改变。
