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. This 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. The position integrates safety risk management activities of the product into their medical, business, and regulatory context and serves as the safety representative in cross-functional development teams and post-marketing product teams. It is responsible for setting safety strategy for these global projects and ensuring alignment with safety objectives expected by internal and external stakeholders.

• Oversee safety management teams to ensure a thorough and consistent approach to the review of safety data from clinical trials and the post-marketing environment.
• Oversee the safety signal detection and medical signal evaluation process.
• Oversee 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.
• Ensure timely production of aggregate reports and responses to queries from Health Authorities according to consistent quality standards.
• Respond to Regulatory Agency requests relating to patient safety in a timely and concise manner.
• Ensure 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.
• Oversee all processes that lead to the production of safety sections and content of relevant clinical trial documents, including protocols, investigator brochures, informed consent forms, and clinical study reports.
• Oversee development of core safety information for new products.
• Set strategy, review, and approve key filing documents including Integrated Summary of Safety (ISS), Summary of Clinical Safety (SCS), and risk management plans (RMPs).
• Provide major contributions to current and potential safety issues, proactively addressing safety issues and setting up additional systems to mitigate risk in CSLB’s studies.
• Give guidance on various medical, product-related, and process-related matters in a complex medical and scientific environment.
• Chair the Safety Management Team (SMT).
• Represent GSPV in relevant cross-functional teams.