• Reporting to the SVP, Drug Safety and Pharmacovigilance, the Senior Director is responsible for supporting the development and implementation of a risk management system for risk detection, risk assessment and risk minimization for investigational and marketed products. • Oversee risk management plan activities including signal tracking maintenance, ad hoc Health Authority requests and the planning and preparation for aggregate safety reports including DSURs, PADERs and PBRERs for Nuvalent’s products. • Close collaboration with DSPV Safety Physicians to analyze potential safety issues, including signal detection, signal evaluation and signal management. • Collaborate proactively with study teams, cross-functional team members, external business partners and vendors to apply knowledge and analytical skills to problems in specific therapeutic areas. • Assist in the evaluation of potential safety issues and quality risk assessment reports. • Coordinate and develop Risk Management Plans for Nuvalent’s products among multiple stakeholders. • Manage and support the authoring for aggregate safety reports (e.g., DSUR, PBRER, PADER) in close collaboration with clinical, medical writing and operational functions.