Global Safety Lead — CSL Behring
CHF 68'000 - 103'000
CSL Behring · Glattbrugg (ZH)
- Location
- Glattbrugg
- Contract
- full-time
- Posted
- 31 days ago
SalaryCHF 68'000 - 103'000
Role overview
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 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.
- 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.
- 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
- Risk assessment
- Signal and Risk Management (literature searches, RWE integration, prioritization, escalation, causality, confounding, lifecycle risk monitoring) Use of technology in signal detection
Main 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
- Oversees 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.
What the company offers
- 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 About CSL Behring
- CSL Behring is a global biotherapeutics leader driven by our promise to save lives.
- Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.
- We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
Application process
- 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.
Additional details
- 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
- Clinical Safety Representation: Chairs the SMT; represents GSPV cross‑functionally Job Specifications:
- 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
- Product development and cross‑functional scientific principles Due diligence processes
Notes and original content
- 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
- Clinical Safety Representation: Chairs the SMT; represents GSPV cross‑functionally
- Job Specifications:
- Previous experience in Gene therapy safety - desirable
- Subject Matter Knowledge:
- Scientific data, Hematology knowledge (including non-oncology), competitive landscape
- Data management and statistical methods
