Celgene’s commitment to drug safety surveillance activities
Every Celgene employee has a role in monitoring and reporting to help ensure the safe use of our products. The Celgene Global Drug Safety & Risk Management Department has more than 170 staff dedicated to safety monitoring via the Global Safety Network (GSN), an entity that spans every country in which Celgene is present including Ireland.
The role of Celgene’s safety department
Celgene’s Global Drug Safety & Risk Management department ensures comprehensive safety monitoring by involving itself in every step of the clinical development process. Safety personnel are embedded within clinical development and project teams to ensure continuity of safety assessment at every stage from pre- to post-marketing.
How effective are Celgene’s safety systems?
Since the early days of Celgene, the company has been a leader in effective safety surveillance systems as a component of its broader risk management programs. As the company that brought Thalidomide Celgene™ (thalidomide) to the marketplace, we have not only met, but have had to exceed expectations for excellence in patient safety. Safety is deeply engrained in our culture.
Our commitment to excellence is evident in results of our regulatory inspections. Despite an unprecedented number of inspections worldwide of Celgene’s drug safety systems, the outcomes have been consistently positive – this is a source of great pride for us. In addition to these outcomes, Celgene subjects its safety programmes to independent external benchmarking that compares our activities to more than 15 other leading biopharmaceutical companies. The results speak for themselves: Celgene consistently places among the highest performing companies.
Date of preparation: November 2017