Executive Director, Pharmacovigilance Operations

Job description

Overview The Executive Director, Pharmacovigilance (PV) Operations is responsible for leadership and oversight of Xeris’ product safety surveillance activities to ensure the safety profile of investigational and marketed products. Verifies that product safety activities follow standard operating procedures, regulatory safety and pharmacovigilance global regulations and requirements. Develops procedures to ensure compliance with appropriate regulations and quality standards for all products from pre-approval to on-market support. Responsibilities: - Leads global PV Operations, develops, maintains, and implements PV policies and procedures to ensure compliance with global regulations and requirements. • Provides oversight of safety reporting by third party providers (e.g., PV CROs), including the review and monitoring of compliance through monitoring reports and other oversight activities and ensures the implementation of effective corrective and preventative action plans. • Responsible for the accurate and timely reporting of ICSRs to Health Authorities in accordance with SOPs and global regulations and requirements. • Responsible for the timely regulatory reporting of Serious Adver...