PLocated 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. /ppThe 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. /ppThe 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. /ppStrong product knowledge is needed for success in the role. Gene Therapy safety experience is a plus. /pppbResponsibilities and Accountabilities (not exhaustive): /b /p /pliSafety Surveillance and Risk Management:Oversees safety management teams ensuring consistent review of safety data from clinical trials and post‑marketingOversees signal detection and evaluationOversees analysis of aggregate safety data and production of DSURs, PSURs, RMPs /liliQuality Management: Ensures timely production of aggregate reports and responses to Health Authorities /liliRegulatory Agency Requests: Provides timely responses regarding patient safety /liliInspections: Ensures inspection findings and internal audit findings are addressed /liliClinical Safety Development: Oversees safety sections of protocols, IBs, ICFs, CSRs; develops core sa...