Executive Director, Pharmacovigilance Operations
Xeris Pharmaceuticals, Inc., Chicago, IL, United States
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 ICSS RS to Health Authorities in accordance with SOPs and global regulations and requirements.
Responsible for the timely regulatory reporting of Serious Adverse Events received during clinical trials.
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.
Responsible for developing or updating of drug safety & PV quality and compliance-related SOPs, Working Instructions, and job aids.
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).
Responsible for the implementing and updates of appropriate safety management plans (SMP), joint operating guidelines (JOG), vendor oversight plan, etc.
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.
Assists in preparation and submission of PV aggregate safety reports (e.g. DSUR, PSURs) in accordance with regulatory requirements and standard operating procedures.
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.
Provides safety content review of clinical study protocols, IBs, ICFs, CSRs, and other safety related documents as needed.
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.
Responsible for ensuring the physicians enrolled in the Keveyis Special Access Program (SAP) in Canada are provided instructions on their responsibilities to report AEs.
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.
Supports PV project management activities (e.g. organize safety team meetings, maintains safety project timelines, takes meeting minutes, archives safety-related documents, etc.).
Manages PV vendor contracts, agreements and management of invoices and budget related activities.
Qualifications
Life sciences or healthcare professional degree (e.g., MD, PhD, PharmD, PA, MS, RN)
A minimum of 15 years of experience in a pharmaceutical company or CRO, with minimum 5 years directly related to PV operations
Proven record in leading/managing PV Operations team and/or PV CROs.
Experience with safety data, expedited individual and aggregate periodic safety reporting, signal generation, safety evaluation and risk management and mitigation strategies
Experience working in small-mid size company in rare disease
Excellent team / project leadership skills
Ability to make effective decisions and manage several high-priority, fast-paced activities within required timelines
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
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.
#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
#J-18808-Ljbffr
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 ICSS RS to Health Authorities in accordance with SOPs and global regulations and requirements.
Responsible for the timely regulatory reporting of Serious Adverse Events received during clinical trials.
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.
Responsible for developing or updating of drug safety & PV quality and compliance-related SOPs, Working Instructions, and job aids.
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).
Responsible for the implementing and updates of appropriate safety management plans (SMP), joint operating guidelines (JOG), vendor oversight plan, etc.
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.
Assists in preparation and submission of PV aggregate safety reports (e.g. DSUR, PSURs) in accordance with regulatory requirements and standard operating procedures.
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.
Provides safety content review of clinical study protocols, IBs, ICFs, CSRs, and other safety related documents as needed.
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.
Responsible for ensuring the physicians enrolled in the Keveyis Special Access Program (SAP) in Canada are provided instructions on their responsibilities to report AEs.
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.
Supports PV project management activities (e.g. organize safety team meetings, maintains safety project timelines, takes meeting minutes, archives safety-related documents, etc.).
Manages PV vendor contracts, agreements and management of invoices and budget related activities.
Qualifications
Life sciences or healthcare professional degree (e.g., MD, PhD, PharmD, PA, MS, RN)
A minimum of 15 years of experience in a pharmaceutical company or CRO, with minimum 5 years directly related to PV operations
Proven record in leading/managing PV Operations team and/or PV CROs.
Experience with safety data, expedited individual and aggregate periodic safety reporting, signal generation, safety evaluation and risk management and mitigation strategies
Experience working in small-mid size company in rare disease
Excellent team / project leadership skills
Ability to make effective decisions and manage several high-priority, fast-paced activities within required timelines
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
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.
#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
#J-18808-Ljbffr