南京招聘

Position Summary 

Manages drug safety medical review, signal evaluation and riskmanagement, and distributes reports and data to both internal andexternal parties following applicable regulations, SOPs and internalguidelines. Provide operational support across all safety service linesas appropriate. 

Key Responsibilities 

Conduct Safety Medical Review 

1. Perform single case medical assessment, including the determinationof seriousness, expectedness / listedness, and causality of adverseevents in compliance with current regulations, internal and externalguidance documents, Standard Operating Procedures, and case processing /coding conventions. 

2. Develop aggregate safety reports required by regulatory agencies,when authorized to perform this function on behalf of a client. 

3. Identify and evaluate safety signals based on individual cases andcumulative data assessment. Communicate these findings proactively andeffectively to the key stakeholders. 

4. Develop safety risk management strategy and plan through theidentification, assessment, communication, and minimization of risk forthe products per client or project needs. 

5. Provide medical advice and insights to department colleagues toimprove the quality, consistency, accuracy, and clinical relevance ofsafety reports. 

6. Develop and maintain comprehensive and current knowledge for theassigned project and product portfolio. 

7. Develop and maintain a comprehensive working knowledge of currentregulations governing the processing and reporting of safety data,Standard Operating Procedures, and case processing / coding conventions. 

8. Support medical and safety monitoring on clinical developmentprojects as needed. 

9. Develop therapeutic area knowledge and safety medical review processexpertise. 

Support Project Management and Contribution to Team Result 

1. Support the achievement of the team case processing performancetimelines. 

2. Liaise with clients and relevant parties, e.g. project management,clinical, data management, investigators, medical monitors, and sitecoordinators to address project issues and identify issue resolution. 

3. Assist with administrative support e.g. project start-up tasks,creation and maintenance of project files, systems access requests,coordinating team/department/customer/project oversight group meetings. 

4. Collaborate cross Drug Safety & Pharmacovigilance sub-functionlines for seamless cooperation on projects and service delivery. 

Comply with Regulatory and Quality Requirements 

1. Ensure consistency and quality of the medical review process. 

2. Ensure compliance to all necessary dMed standard operating procedures(SOPs) and customer SOPs, and all required trainings are executed in atimely manner and documented. 

3. Take responsibility for audit/inspection readiness forpharmacovigilance medical review activities; support audit andregulatory authority inspections when needed. 

4. Learn regulatory requirements and policy changes to apply to the workfor compliance. 

Professional Experience and Education Requirements 

1. Medical Degree from an accredited institution. 

2. Experience as a licensed physician in clinical practice is a plus. 

3. Minimum of two years of relevant experience in pharmacovigilance orclinical research. 

4. Working knowledge of international regulations and guidance documentsgoverning safety evaluation and reporting. General knowledge aboutclinical development process. 

Key Competency Requirements 

1. Knowledge of pharmacovigilance processes or in particularpharmacovigilance function line; willingness and aptitude to learn newskills across pharmacovigilance service lines. 

2. Good understanding of applicable global, regional, local clinicalresearch regulatory requirements; i.e. Good Clinical Practice (GCP) andInternational Conference of Harmonization (ICH) guidelines, StandardOperating procedures (SOPs). 

3. Excellent attention to detail and accuracy and maintain consistenthigh-quality standards. 

4. Ability to follow instructions / guidelines, plan own work, workindependently with can-do attitude. 

5. Ability to be flexible and receptive to changing process demands. 

6. Ability to establish and maintain effective working relationshipswith coworkers, managers and clients. 

7. Fluency in oral and written English, with solid capability in writingmedical and scientific materials or content. 

全球知名生物医药企业资深研发团队打造的创新服务公司。让你的职场起点更高，更充满挑战和精彩。
 
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:
· 临床试验全程及专业领域服务：临床试验设计、数据管理及系统开发、生物统计及编程、运营和项目管理、报告撰写、注册运作和策略、质量保证和稽查、药物安全警戒和风险管理
· 战略咨询服务：临床开发和注册策略、研发功能和架构设计、技术支持和国际化支持。
 
为什么选择我们？
 
· 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。
· 缔脉致力于通过系统培训，研发实践和开放式文化培养新一代生物药物研发国际化人才。
 
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。