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Development China Safety Liasion(J16358)

辉瑞中国

40-60k·12薪 10个工作日内反馈

上海

硕士及以上 10年以上 语言不限 年龄不限
Development China Safety Liasion(J16358) 辉瑞中国

40-60k·12薪 绩效奖金 带薪年假 交通补助

应聘职位
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  • 绩效奖金
  • 带薪年假
  • 交通补助
  • 通讯津贴
  • 定期体检
  • 弹性工作
  • 年度旅游
  • 技能培训
  • 岗位晋升
  • 五险一金

职位描述:

工作职责:
DC Safety Liaison director role:
Manage all CRDC cross functional activities related to safety as assigned, develop DC RMP strategy annually
Act as a Point of Contact for Safety in the DC, ensuring a unified communication on safety matters and representing DC position(s) on safety risk management plan.
Work as Development China (DC) representative to be part of the RMP development and implementation team
Plan RMP development, revision, translation, validation and tracking. Define the RMP China contributors to each required section/question which are requested by Global RMP owner or RMP author. Organize RMP China contributors to participate the RMP review meeting via RMC (risk management committee) or the product risk management strategy (PRMS) sub-team.
Lead RMP development team assess HA correspondence. Organize RMP implementation kick off meeting to work out implementation plan of non-routine RMP activities. Submission of Periodic Study Report.

Engages in inspection readiness and support, and due diligence activities.
Contributes to review and development of local WI, intradepartmental policies and procedures as appropriate.
Initiates, conducts and chairs Risk Management Plan Committee with appropriate oversight.
Review and contributes to written safety assessments and benefit-risk evaluations.
Reviews and tracking safety assessments/evaluations/contributions prepared by senior manager SRLs and other safety colleagues.
Completes all assigned activities with minimal guidance.


MD
Makes decisions based on clinical experience.
Utilizes knowledge of integrated body systems’ pathophysiology to evaluate the impact of product issues.
Assesses the suitability of biopharmaceutical products on typical physician practice within various health systems, hospital and non-hospital patient care facilities.
Ensures products fulfil quality medical care.
Innovative technology related to safety in development
Responsible to lead Dev China, in line with the DC and global strategy, to:

Support to develop Volume 3 China strategy. Leads teams that set strategic direction. Influences senior management decisions that have an impact on business direction, especially in the safety related objectives
Improve the efficiency of our work by adopting innovations in clinical research, especially in the post marketing studies (PMS) , RWE, PAC with safety purpose.
Anticipates, oversees and influences change that has a transformational impact in safety related area

Support and Cooperate with other colleagues within CRDC Strategy and Technology Innovation

Support Head of DC Strategy and Technology Innovation on decision making by collecting and summarizing product safety information; contribute to safety strategies for DC and lead matrix team projects or meetings as required.
Drive and implement Innovation program in safety strategy
Input for the overall external KOL management, especially on those related to safety


Technical Skill Requirements
Technical Skills, (plus knowledge, experience and ability in):
Safety data review, Safety data assessment, Clinical Safety signal identification, risk identification and risk management. Understands aggregate safety data and signal assessment, and performs benefit-risk assessments. From a medical perspective, independently evaluates safety data, identifies and independently analyzes safety signals, and presents the medical evaluation of safety signals to the appropriate forums.
Matrix safety team leadership
Understanding of the scientific basis for therapies and drug-induced diseases. Effective interactions with key external subject matter experts including regulatory authorities.




任职资格:
Qualifications (i.e., preferred education, experience, attributes)
Education: MD (physician) degree required (for MD role)
Education: DVM (veterinarian), PharmD (pharmacist), PhD degree
Minimum 10 years of: medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development experience required    
Education: MSc degree (Health Care Related) (for non-MD role)
Minimum 10 years of: medical (e.g. patient care, clinical trial experience/investigator, academic medicine, specialty training and/or board certification), and/ or scientific, and/or pharmacovigilance or and/or drug development experience required    
Disease Area specific knowledge is preferred.
Thorough understanding of Safety Risk Management internal and external environment, including applicable regulations and guidance.
Clinical development and post-marketing experience to have an understanding of safety context across the drug lifecycle
Demonstrated leadership in day-to-day activities and collaborative skills
Demonstrated self-awareness and interpersonal skills
Appropriate external stakeholder engagement skill and professional compliance sense

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企业介绍:

辉瑞公司(Pfizer Inc.)创建于1849年,迄今已有160多年的历史,总部位于美国纽约,是目前全球最大的以研发为基础的生物制药公司。辉瑞致力于运用创新的科学技术以及全球资源来改善每个生命阶段的健康和福祉。
我们的目标是“不断创新为患者带来能显著改善其健康的药物”。我们的使命是“成为一家卓越的创新型生物制药公司”。
2012年辉瑞公司全年合计收入590亿美元,研发投入78亿美元。辉瑞在全球拥有9万多名员工,59家生产基地,业务遍及全球150多个国家和地区。2012年财富全球500强企业中辉瑞排名126位。
目前辉瑞公司的产品覆盖了包括化学药物、生物制剂、疫苗、健康药物、动物保健品等用于人类、动物和消费者保健等诸多广泛而极具潜力的治疗及健康领域,同时其卓越的研发和生产能力处于全球领先地位。
在人类和动物药品的发现、开发和生产过程中,辉瑞始终致力于奉行严格的质量、安全和价值标准。每天,分布在世界各地的辉瑞员工致力于促进当地医疗卫生的发展以及探索能够应对当今最为棘手疾病的预防和治疗方案。
辉瑞还与世界各地的医疗卫生专业人士、政府和社区合作,支持世界各地的人们能够获得更为可靠和可承付的医疗卫生服务。这与辉瑞作为一家世界领先的生物制药公司的责任是一致的。160多年来,辉瑞一直努力为人们提供更好、更优质的服务。
辉瑞生物制药目前在华上市的创新药物已超过50个,其治疗领域涵盖了心脑血管及代谢、抗感染、中枢神经、抗炎镇痛、抗肿瘤、泌尿、疫苗及等诸多领域。其中如立普妥®、络活喜®、万艾可®、舒普深®、希舒美®、沛儿®、索坦®许多产品在市场上处于领先地位。为了让中国的广大患者能及时接受与全球同步的先进的药物治疗,辉瑞未来将进一步加大和加快在华新药引进和上市的力度和速度。
辉瑞健康药物旗下的善存®、钙尔奇®、惠菲宁®等消费保健产品也在中国市场家喻户晓,并以其优异的品质深受广大消费者的青睐;辉瑞旗下的硕腾动物保健品*为中国的动物保健市场提供各类领先的动物疫苗和动物药品。

At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products of healthcare industry and many of the world's best-known healthcare products such as Centrum. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 160 years, Pfizer has worked to make a difference for all who rely on us.

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