Global Safety Lead - Formulation Safety

Located within CSLB’s GSPV department, the Director, Global Safety Lead, Formulation Safety provide 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. (S)He 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. It is responsible for setting safety strategy for these global projects. Strong product knowledge is needed for success in the role.

The role ensures that the medical and process standards de...

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