• Provide oversight for work performed by pharmacovigilance vendor(s) including compliance, KPI, etc. • Participate in process improvements and vendor-client Safety Management Plans • Accountable for business integration including safety data migration • Accountable for development or revision of SOPs, work instructions, guidance in regard to all functions within PV • Participate in investigator meetings as needed to train investigators and qualified site personnel • Review SAEs for medical/regulatory content and accuracy per protocol requirements • Manage and facilitate SAE reconciliation across projects • Accountable for Quality Management System within PV including compliance, best practices, and continuous process improvements • Work closely with EU and local Qualified Person to develop or maintain pharmacovigilance processes supporting both development and marketed/commercial products • Develop SDEAs or pharmacovigilance agreements for safety data exchange • Collaborate with Clinical Development and Clinical Operations to improve safety reporting processes • Lead HA inspections of Crinetics’ pharmacovigilance function • Responsible for PV budgets and vendor management