What are the responsibilities and job description for the Global Safety Lead position at CSL?
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 in the role. Gene Therapy safety experience is a plus.
Responsibilities and Accountabilities (not exhaustive):
- Safety 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
-Ovrsees analysis of aggregate safety data and production of DSURs, PSURs, RMPs
- Quality Management: Ensures timely production of aggregate reports and responses to Health Authorities
- Regulatory Agency Requests: Provides timely responses regarding patient safety
- Inspections: Ensures inspection findings and internal audit findings are addressed
- Clinical 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
- Clinical Safety Representation: Chairs the SMT; represents GSPV cross‑functionally
Job Specifications:
- MD (Medical Doctor degree) or international equivalent.
- 2 years working experience as a physician in patient care.
- 10 years industry experience, including 5 in safety&PV roles
- Previous experience in Gene therapy safety - desirable
Subject Matter Knowledge:
- Scientific data, Hematology knowledge (including non-oncology), competitive landscape
- Data management and statistical methods
- Benefit–Risk assessment
- Signal and Risk Management (literature searches, RWE integration, prioritization, escalation, causality, confounding, lifecycle risk monitoring)
- Use of technology in signal detection
- Predicting risks and drafting mitigation strategies
- PV & RnD acumen: governance, business environment, PV concepts (CIOMS, expectedness, causality, AE grading, ICSR mgmt.)
- PV documents (PBRER, RMP) and safety sections of regulatory documents
- Labeling principles and regional differences
- Product development and cross‑functional scientific principles
- Due diligence processes