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PV Physician/藥物警戒醫(yī)生

3-4萬(wàn)
  • 北京朝陽(yáng)區(qū)
  • 大望路
  • 10年以上
  • 碩士
  • 全職
  • 招1人

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  • 同事很nice
  • 工作環(huán)境好
  • 免費(fèi)班車
  • 人際關(guān)系好
  • 團(tuán)隊(duì)執(zhí)行強(qiáng)
  • 氛圍活躍
  • 交通便利
  • 管理人性化

職位描述

藥品警戒不良事件醫(yī)學(xué)評(píng)估臨床試驗(yàn)安全臨床數(shù)據(jù)整理臨床研究
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.
Qualification
Essential Knowledge & Skills
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.
Experience
1、Scientific study and experience in pharmaceutical regulations and R&D processes.
2、Pharmaceutical industry experience including a PV responsibility and PV Physician role required.
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工作地點(diǎn)

北京朝陽(yáng)區(qū)華貿(mào)購(gòu)物中心

職位發(fā)布者

李女士/HR

昨日活躍
立即溝通
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康龍化成(北京)新藥技術(shù)股份有限公司(股票代碼:300759.SZ/ 3759.HK)是國(guó)際領(lǐng)先的生命科學(xué)研發(fā)服務(wù)企業(yè)。自2003年成立以來(lái),康龍化成一直致力于人才培養(yǎng)和設(shè)施建設(shè),為包括小分子、大分子和細(xì)胞與基因治療藥物在內(nèi)的多療法藥物研發(fā)打造了一個(gè)貫穿藥物發(fā)現(xiàn)、臨床前及臨床開(kāi)發(fā)全流程的研發(fā)生產(chǎn)服務(wù)體系??谍埢稍谥袊?guó)、美國(guó)、英國(guó)均開(kāi)展運(yùn)營(yíng),擁有19,000多名員工,向北美、歐洲、日本和中國(guó)的合作伙伴提供研發(fā)解決方案并與之保持良好的合作關(guān)系。(詳情請(qǐng)?jiān)L問(wèn)公司網(wǎng)站:www.pharmaron.com)
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