PPD is a leading global contract research organization providing discovery, development and post-approval services as well as compound partnering programs. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 32 countries and more than 9,000 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help its clients and partners maximize returns on their R&D investments and accelerate the delivery of safe and effective therapeutics to patients
Post: Safety Specialist
Job Description:
Working within the drug safety team, you will be responsible for the overall co-ordination of the serious adverse event (SAE) processes as well as the co-ordination of database activities for projects. You will maintain knowledge and understanding of PPD SOPs and WPDs; current global regulations and ICH/local guidelines regarding clinical trials, regulatory documents and safety issues; and effectively interface with project teams, client company, and investigators regarding SAE activities. The Safety Specialist is involved in the preparation and revision of department SOPs and WPDs as well as preparing for and attending audits.
Candidate Profile:
Candidates should have a Life Sciences degree or be a licensed health care professional.
Previous experience in a pharmaceutical, clinical or healthcare setting (preferable in PVG/drug safety). This experience should ideally include experience in all stages of the PVG process and a proven understanding of all relevant ICH guidelines.
Essential
Candidates should have a Life Sciences qualification or be a licensed health care professional.
Desired
Previous experience in a pharmaceutical, clinical or healthcare setting (preferable in PVG/drug safety) will be an advantage. This experience should ideally include experience in all stages of the PVG process and a proven understanding of all relevant ICH guidelines.
Additional Information:
Location: Europe, Middle East & Africa - UK - Scotland - Bellshill - Fleming House 1
Education: B.Pharm, M.Pharm, BS, MS - Life Sciences
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CR
Job Code: 104232
End Date: 15th Nov., 2011
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