Global Safety Lead - Formulation Safety

Located within CSLB’s GSPV department, the Director, Global Safety Lead, Formulation Safety 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 applies 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. Safety risk management activities are integrated into the medical, business, and regulatory context. The role serves as the safety representative in cross-functional development teams and post-marketing product teams, setting safety strategy for global projects. Strong product knowledge is needed for success in the role. The role ensures that medical and process standards delivered in CSLB align with safety objectives expected by internal and external stakeholders, including regulators, governmental agencies, payors, physicians, patients and the general public.

• Oversees safety management teams, ensuring a thorough and consistent approach to the review of safety data from clinical trials and the post-marketing environment.
• Oversees safety signal detection and medical signal evaluation processes.
• Oversees analysis of aggregate safety data and production of key company documents such as DSURs, PSURs, and risk management plans relating to the safety of medicinal products.
• Ensures timely production of aggregate reports and answers to queries from Health Authorities according to consistent quality standards.
• Responsible for timely and concise responses to Regulatory Agency requests relating to patient safety.
• Ensures regulatory agency inspection findings and internal audit findings relating to products of responsibility are addressed and Corrective Action Plans (CAPA plans) are implemented efficiently and effectively.
• Oversees all processes leading to the production of safety sections and content of relevant clinical trial documents, including protocols, investigator brochures, informed consent forms, and clinical study reports.
• Oversees development of core safety information for new products.
• Sets strategy, reviews and approves key filing documents including Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), and risk management plans (RMPs).
• Provides major contributions to current and potential safety issues, proactively addressing safety issues and setting up additional systems to mitigate risk in CSLB’s studies.
• Gives guidance on various medical, product-related and process-related matters in a complex medical and scientific environment.
• Chairs the Safety Management Team (SMT).
• Represents GSPV in relevant cross-functional teams.