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.
Previous PVG/drug safety experience is essential within a pharmaceutical, clinical or healthcare setting . This experience should ideally include experience in all stages of the PVG process and a proven understanding of all relevant ICH guidelines.
Candidates should have a Life Sciences qualification or be a licensed health care professional.
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 45 countries and more than 11,500 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.