职位描述：
Major Responsibility
Manage collection, processing, documentation, reporting and follow-up of all adverse events reports for all Novartis products from clinical trials, post-marketing studies (PMS), Spontaneous Reports (SR), registries, commercial programs, etc.
Ensure accurate and consistent transcription, translations and data entry of all SeriousAdverse Events (SAE) from source documents onto safety systems (e.g. SINA, etc)with emphasis on timeliness and quality.
Manage reporting/submission/distribution of safety reports/updates/information (e.g. SAE,SR, IN, PSUR, ASR) to Local Health Authority (LHA) and/or clinical operations.
Set up, update and implement local procedures to ensure compliance with IMS global procedures and Chinese requirements.
Management and maintenance all relevant IMS databases.
Develop and update training materials for pharmacovigilance and ensure training of CPO associates on relevant IMS procedures for AE reporting, including field force and third partycontractor, if applicable.
Ensure support for and close-out of audits, corrective action plan, investigation and HealthAuthority inspections.
Ensure training and oversight of staff, as applicable.
Manage and maintain efficient IMS filing and archive system.
Qualification
Medical background (hospital / clinical research/ Pharmacovigiliance experience prefered)
Knowledge of pharmacological and medical terminology.
Fluent in English and Mandarin
Good communication & presentation skill
Basic IT knowledge
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有意者请将求职信以详细中英文简历和联系电话用以下任一方式寄给我们：
邮寄地址：
北京市朝阳区建外大街1号国贸大厦2座14层
北京诺华制药有限公司 人力资源部
邮政编码：100004
(请在信封左上角注明应聘职位编号及地区)
传真：010-65057306
E-mail：recruit_HR.phcnbj@
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