• Providing oversight and daily management of all activities pertaining to drug safety within the Praxis pharmacovigilance (PV) department globally. • Leadership and oversight of global PV operations, personnel and strategic resource planning. • Oversight of developing compliant PV procedures and training modules. • Oversight of timely safety reporting to regulatory authorities and external business partners. • Implementation of strategies to manage safety risks. • Ensure the PV department maintains inspection readiness, including representing the company during audits and pharmacovigilance inspections. • Monitor key performance indicators for PV vendors. • Collaborate cross-functionally to ensure timely authoring of key safety deliverables including periodic safety updates and regulatory query responses. • Lead PV/safety aspects of NDA/MAA preparation, including authoring of integrated safety summary and drafting labeling. • Leads capabilities enhancement within PV, including implementation of safety database and data visualization tools for signal detection. • Oversight of relationships with external business partners, including overseeing the alliance, associated requests, and PV agreements, ensuring mechanisms are in place for governance of partnerships.