南京招聘

Position Summary
Develop relevant safety AR and risk management document to meet the requirements from both of
internal and external parties following applicable regulations, SOPs and internal guidelines. Provide
operational support across all safety service lines as appropriate.

Key Responsibilities

• Development of relevant safety AR and risk management document

1. Work as authors to relevant safety AR and risk management document, including but not limit to Risk Control Plan (RCP), Development Safety Update Report (DSUR), Periodic Benefit Risk Evaluation Report / Periodic Safety Update Report (PBRER/PSUR) and Risk Management Plan (RMP), etc.
2. Support/lead end-to-end preparation of aggregate safety reports. Support coordination of relevant table and listings to ensure information received, analyzed and incorporated into aggregate safety reports as per the regulatory requirements.
3. Support independent QC of AR to ensure the information presented in AR is complete, consistent and compliant to regulatory requirement. Adhere to good documentation practices.

• Support Project Management and Contribution to Team Result

1. Attend internal and customer project team meetings (face-to-face, online or via teleconference) as defined in the scope of work (SOW) and budget. Attend planning meetings, data interpretation meetings, online documents review meetings, as required.
2. Perform delegated project lead activities with supervision. Lead responsible projects and ensure all activities are completed on time and meet quality standards Provide mentoring to team members as needed 
3. Work closely with case processing service operations to resolve issues as needed
4. Interface with other functional groups in project bases, such as Regulatory Affairs & Strategy, Clinical Science & Medical Affairs functions, Quality Assurance, Business Technology & Innovation, or other business units as needed
5. Lead or participate in project teams and committees as assigned.
6. Alert the Safety Physicians of potential safety issues and assist the Safety Physicians in monitoring the safety profile of products.
7. Contribute to SOP development and optimization.

• Comply with Regulatory and Quality Requirements

1. Ensure compliance to all necessary dMed standard operating procedures (SOPs) and customer SOPs, and all required trainings are executed in a timely manner and documented.
2. Take responsibility for audit/inspection readiness for pharmacovigilance risk management activities; support audit and regulatory authority inspections when needed.
3. Learn regulatory requirements and policy changes to apply to the work for compliance.

Education and Key Competency Requirements

1. Bachelor’s degree in Nursing, Medical Technology or Pharmacy with 2+ years of clinical experience or Life Science degree and 1 year of pharmacovigilance experience.
2. Preferably, at least 2 years of experience in safety/ medical/scientific/regulatory writing.
3. Excellent understanding of drug development process, GCP and medical terminology.
4. Good knowledge of pharmacovigilance processes; willingness and aptitude to learn new skills across pharmacovigilance service lines.
5. Good understanding of applicable global, regional, local clinical research regulatory requirements; i.e. Good Clinical Practice (GCP) and International Conference of Harmonization (ICH) guidelines, Standard Operating procedures (SOPs).
6. Ability to follow instructions / guidelines, plan own work, work independently with can-do attitude.
7. Fluency in oral and written English, with solid capability in writing medical and scientific materials or content.

备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。

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我们是谁？
 
    基于中国面向全球制药，生物技术和医疗器械公司的临床开发服务和解决方案提供商:
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· 缔脉定位于以高品质服务和专业精神成为业界典范。
· 缔脉管理层在中国生物医药研发领域耕耘十多年培养了1000+优秀人才。
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创始人及部分核心专业领域


创始人 - 谭凌实博士：拥有20多年跨国一流制药公司总部高级管理经验。此前担任辉瑞公司全球药物开发运营副总裁，在中国成功创建了首屈一指的研发中心，且经历10多年发展壮大到多个地点，成为辉瑞全球核心的研发中心之一，承担药物临床开发、安全风险管理、注册、临床稽查等关键职能。谭博士多年为RDPAD, DIA 的核心成员，担任重要职务,包括研发委员会主席, 全球董事等。谭博士还带头建立了与国内一流高校的教育培训合作，比如复旦大学、北京大学，交通大学。培养了不少拥有专业技能和行业知识的临床数据管理和编程人才。谭博士有在美国建立初创企业的经验，且在美国一流制药企业研发中心工作多年。谭博士拥有生物统计博士学位。