Drug Safety Leader-pharma/CRO
摹根麦肯立人才服务（上海）有限公司
- 公司规模：少于50人
- 公司行业：专业服务(咨询、人力资源、财会) 中介服务
职位信息
- 发布日期：2012-11-09
- 工作地点：北京
- 招聘人数：若干
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：英语熟练
- 职位类别：生物工程/生物制药 药品生产/质量管理
职位描述
Key Accountabilities
? Develop project specific safety reporting procedures and workflows and provide guidance
to the team on the procedures
? Develop project specific safety database customization and data entry guidelines
? Triage of incoming reports for completeness, legibility and validity
? Initial data entry of case reports into safety database / tracking system
? Assessment of case reports for seriousness, causality and expectedness
? Requesting follow-up i.e. written, telephone
? Adverse event (AE) and drug coding
? Writing case narratives
? Case reconciliation _ coordinating activities with Data Management personnel
? Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc
safety reports etc
? Quality control of case reports, line listings and tabulations
? Maintaining local drug safety reporting requirements
? Regulatory authority reporting (electronic and hard copy)
? Literature reviews
Skills
? Sound knowledge of drug safety and the drug development process
? Knowledge of and ability to interpret and apply global safety regulations.
? Experience in data analysis and evaluation of safety data
? Demonstrated competence in processing, evaluating and reporting safety information in
compliance with the regulations
? Good presentation skills
? Excellent interpersonal skills
? Excellent verbal / written communication skills
? Good time management skills
? Team player
? Client focused approach to work
? Experience with computer applications including database management and pharmacovigilance
related computing systems
If you are interested in the opportunity,you can send me your resume to me via jhuang@morganmckinley.com
? Develop project specific safety reporting procedures and workflows and provide guidance
to the team on the procedures
? Develop project specific safety database customization and data entry guidelines
? Triage of incoming reports for completeness, legibility and validity
? Initial data entry of case reports into safety database / tracking system
? Assessment of case reports for seriousness, causality and expectedness
? Requesting follow-up i.e. written, telephone
? Adverse event (AE) and drug coding
? Writing case narratives
? Case reconciliation _ coordinating activities with Data Management personnel
? Line listing and tabulation generation for safety reports i.e. periodic safety reports, ad hoc
safety reports etc
? Quality control of case reports, line listings and tabulations
? Maintaining local drug safety reporting requirements
? Regulatory authority reporting (electronic and hard copy)
? Literature reviews
Skills
? Sound knowledge of drug safety and the drug development process
? Knowledge of and ability to interpret and apply global safety regulations.
? Experience in data analysis and evaluation of safety data
? Demonstrated competence in processing, evaluating and reporting safety information in
compliance with the regulations
? Good presentation skills
? Excellent interpersonal skills
? Excellent verbal / written communication skills
? Good time management skills
? Team player
? Client focused approach to work
? Experience with computer applications including database management and pharmacovigilance
related computing systems
If you are interested in the opportunity,you can send me your resume to me via jhuang@morganmckinley.com
公司介绍
摹根麦肯立于1995年成立于英国，为英国各知名金融机构提供高标准的求职者，是众多投资银行和金融服务领域大型企业的首选合作伙。2005年，摹根麦肯立由Imprint Plc公司并购。公司合并后，如虎添翼，业务全面发展，是欧洲发展最快的人才服务公司。2008年，摹根麦肯立公司被Premier Group收购。目前摹根麦肯立在英国、欧洲大陆、中东及亚太地区拥有21个办公室，成为全球人才服务领域的领导者。