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Job Details

Safety Reporting Specialist-141546

Company: PPD
Location: Europe, Middle East & Africa-UK-England-Cambridge
Reference: 141546
Closing Date: 15 Sep 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

PPD are looking to recruit a Pharmacovigilance (PVG) Safety Reporting Specialist (SRS).  Working within the PVG department, the PVG SRS will submit all submissions with regulatory timelines, to appropriate quality standards and following PPD procedures. The PVG SRS will also assist the Team Manager by producing study metrics (e.g. no. letters submitted for each study per month and so on) as required. ...

Requirements:

PPD are looking to recruit a Pharmacovigilance (PVG) Safety Reporting Specialist (SRS).  Working within the PVG department, the PVG SRS will submit all submissions with regulatory timelines, to appropriate quality standards and following PPD procedures. The PVG SRS will also assist the Team Manager by producing study metrics (e.g. no. letters submitted for each study per month and so on) as required.
 
It is advantageous that the PVG SRS maintains knowledge and understanding of PPD's SOPs and WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues; and effectively interface with  the Clinical Department,  Regulatory Affairs Department, project teams and client company.  The PVG SRS may also get involved in the preparation of department SOPs and WPDs.  He/she also prepares for, and attends audits

 

Qualifications

 Bachelor’s degree  
Minimum 2-3 years medical/clinical experience or clinical/safety 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

PPD is a leading global contract research organization providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations.

With offices in 48 countries and more than 18,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments.

Apply for this job: Safety Reporting Specialist-141546

Contact Information:

Address:  PPD Cambridge
Granta Park
Great Abington
Cambridge

CB21 6GQ
England
Tel:  +44 1223 374100
Website:  Visit Our Web Site

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