Experience authoring key safety documents, including Safety Surveillance Plans (SSPs), Signal Analysis Reports (SARs), Development Risk Management Plans (dRMPs), Development Core Safety Information (DCSI), and contributions to Investigator's Brochures (IBs), Development Safety Update Reports (DSURs), clinical protocols, and informed consent forms. This individual will play a critical role in the ongoing assessment of the benefit-risk profile of investigational products by leading signal detection, safety analyses, and risk management activities while partnering closely with Clinical Development, Regulatory Affairs, Biometrics, and Clinical Operations.