Global Safety Lead

Job description

Located within CSL’s Global Clinical Safety and Pharmacovigilance department, the Global Safety Lead provides expertise on all aspects of clinical safety throughout the entire lifecycle of a product with special emphasis on ongoing evaluation of safety information during clinical development and post approval. The role ensures alignment with safety objectives including compliance with legal requirements and company PV standards, preventing harm from adverse reactions, promoting safe and effective use of medicinal products and contributing to protection of patients and public health. The GSL will apply sound medical judgment for analysis and interpretation of complex clinical safety data for signal detection and initiation of safety risk management activities including safety specification, PV planning and risk minimization/mitigation, integrate safety risk management activities of the product into their medical, business, and regulatory context. The role serves as the safety representative in the cross-functional development teams and post-marketing product teams and is responsible for setting safety strategy for these global projects. Strong product knowledge is needed for success...