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Safety Co-ordinator (part time)

Location:Sydney, New South Wales, Australia
Job Type:Part-time
Posted:16th Jun 2011
Closing Date:14th Jul 2011
Posted By:Kendle
Details:
Safety Co-ordinator (part time)

Kendle's Sydney office has an immediate need for a Safety Data Co-ordinator level I or II to join the organisation on a permanent, part time basis.

The focus of the position is to provide diverse support for the Global Safety department with assignments which may be of a confidential nature. In addition, the role will include:
- compiling and recording serious adverse event (SAE) information as well as distributing information to clients and regulatory authorities within prescribed time limits.
Assisting with administrative support for personnel in the Global Safety department.
Assisting with training of safety personnel.
Duties are varied and include, but are not limited to, the following:
- Assisting with obtaining follow-up safety data/information from study sites.
- Assisting with the completion of necessary forms needed to set-up study specific databases andcomputer applications.
Assisting with preparing study-specific forms/templates.
Assisting with the generation of presentation materials.
Attending, where required, project status meetings and reporting status to management.
Providing, where appropriate, technical leadership on projects for more junior Safety Data Co-ordinators.
Completing QC review of peers, verifying data entered into the Safety database is recorded accurately and reflects the hard copy documentation.
Correcting/modifying all data in Safety database(s) utilizing documentation provided by other Safety personnel.
Ensuring all reference material is current and conventions are replaced or updated as appropriate.
Assisting with reconciliation of the safety and clinical databases as required to identify database discrepancies.
Assisting, where requested, in the training of safety personnel as well as answering questions, sharing knowledge and assisting with resolving problems.
Applications are welcomed from candidates ideally holding a Bachelor's Degree, or equivalent.
This should be further supported by experience of safety case entry experience in a medical setting. Sound knowledge of medical terminology and experience working with either a clinical database or PC in the Windows/Windows NT environment is a prerequisite.
Previous clerical work and/or data processing experience is preferred.
In addition to these skills the candidate must have good organizational skills, be detail oriented and be able to work concurrently on multiple projects.

 
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