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Job Details

Senior Safety Scientist

Company: MSI Group Limited
Location:
Reference: 54879
Closing Date: 18 Aug 17
Type: Permanent
Salary (£): 40,000 - 60,000
Benefits:

Job Summary:

Exciting opportunity to join a Global Pharma Leader based just outside of Oxford in a high profile role.

Requirements:

My Client is a Global Pharma company with an enviable reputation for innovation and progression. 

 

Due to a recent acquisition my Client is seeking a high calibre, Senior Safety Scientist to support Leaders with scientific analyses, data reviews, signal management & risk assessment activities, evaluation of product quality issues & emerging safety issues, including contribution to safety documents.

 

Key responsibilities will include:

 

Providing scientific review & interpretation of safety data for the preparation of aggregate reports such as DSUR's, PSUR's (this includes the management and monitoring of vendors used  to author such documents)
Providing scientific expertise during signal detection activities, signal evaluation and risk assessment and managing the process for the development and management of Risk Management Plans
Working cross-functionally to ensure that Clinical, Franchise and Regulatory objectives are met by reports being submitted according to international regulatory requirements and Company objectives and timelines 
Providing scientific expertise to the preparation of responses to internal & external questions relating to the safety of products on the market or during clinical trials
Delivering efficient & timely review of clinical trial documentation
Providing requisite regular reports of safety data, including appropriate scientific data analysis to support Leaders
Reviewing clinical trials safety data throughout the clinical development programme to ensure that any medical issues are raised with Leaders
Providing an overview of pharmacovigilance definitions and Standard Operating Procedures to study investigators and site monitors at study set-up
Liaise with Global Drug Development CRO's to ensure that SAE data within Databases are accurately reconciled for all clinical trials
Maintaining awareness of changes to regulatory guidance document and regularly review, update & implement pharmacovigilance business procedures

 

The successful incumbent will have a strong awareness of pre- and post-marketing PV legislation coupled with proven scientific analytical skills. Knowledge of product development processes and pharmacovigilance legislation is essential.   

Apply for this job: Senior Safety Scientist

Contact Information:

Address:  Head Office
3rd Floor East, Cottons Centre, 47/49 Hays Lane London SE1 2QE
SE1 1QL
England
Tel:  02079401985
Fax:  02079909763
Website:  Visit Our Web Site

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