Executive Director, Pharmacovigilance Operations

Overview The Executive Director, Pharmacovigilance (PV) Operations is responsible for leadership and oversight of Xerisu2019 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 u2022 Leads global PV Operations, develops, maintains, and implements PV policies and procedures to ensure compliance with global regulations and requirements. u2022 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. u2022 Responsible for the accurate and timely reporting of ICSRs to Health Authorities in accordance with SOPs and global regulations and requirements. u2022 Responsible for the timely regulatory reporting of Serious Adverse Events received during clinical trials. u2022 Interfaces and collaborates with Clinical Development, Biostatistics/Data Management, Quality Assurance, Medical Affairs and Regulatory Affairs and others as needed, to enable safety support for all Xeris products. u2022 Responsible for developing or updating of drug safety & PV quality and compliance-related SOPs, Working Instructions, and job aids. u2022 Responsible for the development and implementation of the global PV training strategy (e.g., training matrix development, process, contribute to the collection, organization, and presentation of all required global PV compliance metrics including vendor and partner oversight metrics). u2022 Responsible for the implementing and updates of appropriate safety management plans (SMP), joint operating guidelines (JOG), vendor oversight plan, etc. u2022 Responsible for the development of PV Agreements (PVA) and/or safety data exchange agreements (SDEA) with license partners and distributors in support of PV collaborations and ensures compliance as outlined in the agreements. u2022 Assists in preparation and submission of PV aggregate safety reports (e.g. DSUR, PSURs) in accordance with regulatory requirements and standard operating procedures. u2022 Leads the management of safety surveillance procedures including signal detection and evaluation related activities by the Safety Management Team in accordance with SOPs and guidelines. u2022 Provides safety content review of clinical study protocols, IBs, ICFs, CSRs, and other safety related documents as needed. u2022 Manages the Enhanced Pharmacovigilance Plan (EPV) and Hepatic Adjudication Committee (HAC) which includes providing summary EPV data for the HAC to review/analyze, running the quarterly meetings, and maintaining records of the cases reviewed and conclusions. u2022 Responsible for ensuring the physicians enrolled in the Keveyis Special Access Program (SAP) in Canada are provided instructions on their responsibilities to report AEs. u2022 Serves as Subject Matter Expertise (SME) for regulatory inspections and audits as well as ensures all safety-related documentation in an inspection/audit-ready state. u2022 Supports PV project management activities (e.g. organize safety team meetings, maintains safety project timelines, takes meeting minutes, archives safety-related documents, etc.). u2022 Manages PV vendor contracts, agreements and management of invoices and budget related activities. Qualifications u2022 Life sciences or healthcare professional degree (e.g., MD, PhD, PharmD, PA, MS, RN) u2022 A minimum of 15 years of experience in a pharmaceutical company or CRO, with minimum 5 years directly related to PV operations u2022 Proven record in leading/managing PV Operations team and/or PV CROs. u2022 Experience with safety data, expedited individual and aggregate periodic safety reporting, signal generation, safety evaluation and risk management and mitigation strategies u2022 Experience working in small-mid size company in rare disease u2022 Excellent team / project leadership skills u2022 Ability to make effective decisions and manage several high-priority, fast-paced activities within required timelines u2022 Competencies: Teamwork & Collaboration, Attention to Detail, Self-Starter, Analytical skills, Problem Solving, Organizational skills, Conflict Resolution, Adaptability, Professionalism, Written and Verbal Communications, Presentation skills, Strategic Vision u2022 Working Conditions: Position may require periodic evening and weekend work, as necessary to fulfill obligations. Periodic overnight travel required. Consideration will be given to remote candidates. Preference will be given to candidates who reside in the Chicagoland area. _The level of the position will be determined based on the selected candidateu2019s qualifications and experience._ _#LI-HYBRID_ _As an equal employment opportunity and affirmative action employer, Xeris Pharmaceuticals, Inc. does not discriminate on the basis of race, color, religion, sex, gender identity, sexual orientation, national origin, age, disability, veteran status, genetics or any other characteristic protected by law. It is our intention that all qualified applications are given equal opportunity and that selection decisions be based on job-related factors._ _The anticipated base salary ranges for this position are Non-MD: $280,000-$350,000 or MD: $340,000-$430,000. Final determination of base salary offered will depend on several factors relevant to the position, including but not limited to candidate skills, experience, education, market location, and business need. This role will include eligibility for bonus and equity. The total compensation package will also include additional elements such as multiple paid time off benefits, various health insurance options, retirement benefits and more. Details about these and other offerings will be provided at the time a conditional offer of employment is made. Candidates are always welcome to inquire about our compensation and benefits package during the interview process._ _NOTE: This job description is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization._ Job Locations _US-IL-Chicago_ Title _Executive Director, Pharmacovigilance Operations_ ID _2026-2373_ Category _Pharmacovigilance Operations_ Type _Full-Time_

Created: 2026-04-04