Associate Safety Specialist - Cambridge

Cambridge, United Kingdom
19 Sep 2019
15 Oct 2019
Full Time
Contract Type
Experience Level
Experienced (non-manager)
The Associate Safety Specialist, working alongside a more experienced member of staff, will coordinate serious adverse event (SAE) processes and database activities, and develop an understanding of budgets and forecasts for assigned projects.

You must be familiar with and understand PPD SOPs and WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues. He/she, alongside a more experienced member of staff, will effectively interface with project teams, the client company and investigators regarding SAE activities.

You may also prepare for and attend audits, kick-off and investigator meetings. The Safety Specialist must demonstrate the ability to prioritize and organize their own workload, which will be assigned by a more experienced member of staff. All accountabilities of an Associate Safety Specialist are carried out with ongoing supervision of a more senior colleague.


Education and Experience:

Bachelor's degree in Life Sciences or Nursing

Minimum 2-3 years medical/clinical experience or clinical/safety experience and 0 - 2 years SAE processing experience

In some cases other appropriate education and professional training, for example vocational Health Care Professional qualifications, certified/licensed health care profession and/or relevant research experience may be substituted provided the individual possesses the required knowledge, skills and abilities

Knowledge, Skills and Abilities:

Competent in the use of Microsoft Word, Excel and PowerPoint

Safety database skills

Good oral and written communication skills

Strong attention to detail

Ability to work within a team or independently as required

Good knowledge of applicable SOPs, ICH GCP and awareness of pharmacovigilance regulations

Ability to review SAE data for completeness and prepare patient narratives from appropriate documentation

Competent at administrative tasks and project administration activities

General understanding of pathophysiology and the disease process, more detailed knowledge of relevant therapy areas as required to process SAEs


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