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You would be a contributor to a Global Team with collective responsibility for regulatory activities associated with global pharmacovigilance including electronic pharmacovigilance system, adverse drug experience (ADE) reports, trending reports, ADE
Evaluate and develop product development strategies for pharmaceutical products (drugs, biologics, advanced therapies) focusing on clinical-commercial convergence that encompasses all phases of development from discovery to market, including preclinical
Act as a scientific and clinical expert in diabetes and CGM, ensuring the organisation remains at the forefront of emerging evidence and practice. Provide authoritative, evidence-based guidance on clinical data, device utilisation, and patient management
Understand and conduct work consistent with GCP, ICH, 21 CFR Part 11, internal SOPs, and international regulatory requirements; Interact with the project statistician and guide other programmers participating in a project completion
Initiating, coordinating and supervising the registration of medicinal products through European procedures (MRP, DCP, CP) or national submissions across all regions of interest; Devising submission strategy for each project, in line with all applicable