PpLocated 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. /p h3Responsibilities and Accountabilities (not exhaustive) /h3 ul liSafety Surveillance and Risk Management: Oversees safety management teams ensuring consistent review of safety data from clinical trials and post‑marketing, oversees signal detection and evaluation, analysis of aggregate safety data and production of DSURs, PSURs, RMPs. /li liQuality Management: Ensures timely production of aggregate reports and responses to Health Authorities. /li liRegulatory Agency Requests: Provides timely responses regarding patient safety. /li liInspections: Ensures inspection findings and internal audit findings are addressed. /li liClinical Safety Development: Oversees safety sections of protocols, IBs, ICFs, CSRs; develops core safety information; reviews ISS, SCS; provides guidance on medical, product, and process matters. /li liClinical Safety Representation: Chairs the SMT; represents GSPV cross‑functionally. /li /ul h3Job Specifications /h3 ul liMD (Medical Doctor degree) or international equivalent. /li liAt least 2 years working experience as a physician in patient care. /li li10 years industry experience, including 5 in safety PV roles. /li liPrevious experience in Gene therapy safety – desirable. /li /ul h3Subject Matter Knowledge /h3 ul liScientific data, Hematology knowledge (including non‑oncology), competitive landscape. /li liData management and statistical methods. /li liBene...