Actively participating in the Signalling Meeting, Drug Safety Committee, and Labelling Committee – and Reviewing or drafting responses to requests on all drug safety matters from Regulatory Authorities for product Reviewing or drafting responses to requests on all drug safety matters from Regulatory Authorities. Involvement for Client products. Actively participating in the Drug Safety Committee – signal detection and risk evaluation writing and risk management. Experience of orphan drug/rare diseases/biologics preferred. Understanding
Actively participating in the Signalling Meeting, Drug Safety Committee, and Labelling Committee – and Reviewing or drafting responses to requests on all drug safety matters from Regulatory Authorities for product Reviewing or drafting responses to requests on all drug safety matters from Regulatory Authorities. Involvement for Client products. Actively participating in the Drug Safety Committee – signal detection and risk evaluation writing and risk management. Experience of orphan drug/rare diseases/biologics preferred. Understanding