The Safety Scientist supports early and late phase development activities as a member of the safety team under the leadership of the Strategy Safety Leader (SSL) providing essential safety oversight and input into all aspects of study management across the entire development portfolio.
In the post-market setting, this role contributes to safety science deliverables required to maintain license to operate and to manage and communicate the evolving safety profile
Responsible for signal detection and signal management activities including, but not limited to STAR maintenance, ISMP maintenance, and drug safety reports
Contributing to risk management activities including preparation and maintenance of CCDS, labeling document maintenance, risk communications, RMP, REMS
Responsible for individual and aggregate case reporting activities including ICSR case management (medical review) and aggregate reporting (i.e. DSUR, PBRER)
Coordinate and assist in responding to Health Authority requests
Profound experience in pharmacovigilance & safety
In-depth experience in hands on signal and risk management activities
Proficient experience in industry (pharma safety)
Excellent understanding of GVPs/GCPs/GxP
BSc/MSc degree in Life Science
Excellent communications skills both written and verbal
Ability to work in a matrix international environment
Option of extension
The client is one of the largest biotech company of the world, is a pioneer in healthcare and a frontrunner in personalised healthcare
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.