Safety Reporting Specialist (Cambridge based)-143619

Recruiter
PPD
Location
Cambridgeshire
Posted
10 Feb 2018
Closes
14 Mar 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
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 comprehensive, integrated drug development, laboratory and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 47 countries and approximately 20,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a firm commitment to quality to help clients and partners bend the cost and time curve of drug development to deliver life-changing therapies that improve health. *LI-LS1 IndeedPPDGBIE

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