[大连]科文斯医药研发（上海）有限公司

职位：Drug Safety Support Specialist（药物警戒）
发布时间：2018-08-21
工作地点：其它
信息来源：前程无忧(51JOB)
职位类型：全职
职位描述
公司官网:ww***com[点击查看] 专业1:制药工程 职能类别:临床数据分析员

Assist in the processing of expedited safety reports (ESRs). This includes, but is not limited to:

maintenance of adverse event tracking systems.

set-up and maintenance of project files, core process files and central safety files.

assist with the reporting of ESRs to clients, regulatory authorities, ethics committees, investigators and Covance project personnel, if required, within study specified timelines.

Provide administrative support to PV&DSS personnel (e.g. word processing, proof-reading and editing correspondence/documents, mailings, filing, faxing, photocopying and archiving etc).

Ensure all incoming faxed Serious Adverse Event (SAE) reports are appropriately stamped, logged into the departmental tracking application and forwarded in a timely manner to the designated Drug Safety Associate (DSA)/Senior Drug Safety Associate (Sr. DSA).

Where applicable, check the PV&DSS hotline mailbox regularly for reported SAEs and forward messages to the designated DSA)/Sr. DSA.

Assist in the maintenance of files regarding adverse event reporting requirements in all countries.

Maintain and distribute a weekly schedule for PV&DSS staff.

Work within the Standard Operating Procedure (SOP) system, including departmental Work Instructions (WIs).

Build and maintain good PV&DSS relationships across functional units.

Ensure submission of client-related documents is sent to the client within designated timeframes (e.g. SAE reports, ESRs, Safety Management Plans (SMPs)).

Assist the DSA/Sr. DSA in preparation of materials needed for client and/or investigator meetings.

Any other duties as assigned by management.

Educated to at least GCSE level or equivalent.

H.S. diploma or equivalent, some college preferred.

Attention to detail.

Team player.

Solid written and verbal communication skills.

Accurate math and spelling skills preferably with an aptitude for handling and proof-reading numerical data.

Knowledge of MS office Windows applications beneficial.

Ability to operate standard office equipment.

Educated to at least GCSE level or equivalent.

H.S. diploma or equivalent, some college preferred.

公司简要介绍：
公司名称:科文斯医药研发（上海）有限公司
公司类型:外资（欧美）
公司规模:500-1000人
公司介绍:Why Covance?
At Covance, you will join like-minded professionals who, together, build our reputation as one of the world's largest and most respected contract research organizations. In choosing Covance, you will be part of a dedicated team that makes a difference in helping to deliver life-saving and life-enhancing medicines to people around the world.
We Offer
Covance’s ongoing success offers team members unsurpassed growth and career development opportunities. At Covance, we help make the miracles of medicine a reality. We offer opportunities to work on diverse, challenging projects with bright, interesting colleagues while building a flexible and rewarding career.

There is no better time to join us!