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Job Details

Senior/Safety Reporting Specialist - Homebased UK/EU - Permanent role

Company: Novella Clinical Resourcing
Location: UK or Europe home based
Reference: NC1718744SAFSPEC
Closing Date: 13 Oct 17
Type: Permanent
Salary (£): On Application
Benefits: Bench marked benefits including pension, life assurance, medical insurance, bonus

Job Summary:

Safety Reporting Specialist or Senior Safety Reporting Specialist urgently required by Novella Clinical, a Quintiles company. Home based role in UK or EU. Candidates must have experience of submitting regulatory safety reports to Regulatory Authorities and Central Ethics Committees.

Requirements:

Novella Clinical, a Quintiles company, has a vacancy for a Safety Reporting Specialist or Senior Safety Reporting Specialist. This role is permanent and can be home based anywhere in the UK or EU. 

 

The main functions of this Safety Reporting Specialist role are:-

·        Review, preparation and submission of safety reports (Expedited and Periodic) to all applicable Regulatory Authorities and Central Ethics Committees and distribution to sites within defined timelines for drug clinical trials and medical device clinical investigations

·        Development of project specific plans related to safety reporting

·        Oversight of third party vendors and timely compliance reconciliation of vendor submissions

·        Involvement in process improvement initiatives across the company

 

REQUIREMENTS

·        Bachelor’s Degree in one of the life sciences or clinical research and a minimum of 1 year of related clinical research experience .

·        Previous clinical trials experience preferably in both medical device and pharmaceutical reporting.

·        Should have experience of global submissions and Eudravigilance submissions.

·        ARGUS and/or Oracle experience preferred.

·        Computer literacy and experience working with Microsoft Office (Word, Excel, and PowerPoint) required.

·        Good written and verbal communication skills.

·        Positive attitude and ability to interact with all levels of staff to successfully coordinate and execute regulatory department activities.

·        Excellent organization skills and ability to handle multiple priorities while adhering to applicable timelines.

·        Ability to work independently, follow instructions/guidelines and demonstrate initiative.

·        Basic knowledge of medical terminology.

·        Good knowledge of the clinical research process and current GCP/ICH guidelines applicable to conduct of clinical research.

·        Fluency in spoken and written English.

 

To apply please submit an English language CV in Word format.

 

Key Words: Safety reporting Specialist, Senior Safety Reporting Specialist, drug safety, regulatory

Apply for this job: Senior/Safety Reporting Specialist - Homebased UK/EU - Permanent role

Contact Information:

Address:  Novella Clinical Resourcing
Ground Floor, Abel Smith House, Gunnells Wood Road, Stevenage, Hertfordshire
SG1 2ST
England
Tel:  +44(0)1438 221122
Fax:  +44(0)870 762 6257
Website:  Visit Our Web Site

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