Safety Reporting Specialist
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. 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. You will also prepare for, and attend audits.
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 47 countries and more than 19,000 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.
This job was originally posted as www.jobsite.co.uk/job/959403228