Liquidia Corporation
Executive Director, Pharmacovigilance Operations
Liquidia Corporation, Morrisville, North Carolina, United States, 27560
Executive Director, Pharmacovigilance Operations
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Executive Director, Pharmacovigilance Operations
role at
Liquidia Corporation
1 day ago Be among the first 25 applicants
Direct message the job poster from Liquidia Corporation
Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.
Job Summary The Executive Director, Pharmacovigilance Operations is responsible for building, leading, and overseeing the strategy, systems, and operational execution of global pharmacovigilance activities for pre- and post-marketing programs for Liquidia. Reporting to the Head of Regulatory Affairs and PV, this role ensures that safety operations, case management, compliance oversight, signal management, and safety governance processes meet all global regulatory requirements. The Executive Director will lead a growing PV Operations team, manage PV vendors, and collaborate closely with Clinical Development, Clinical Operations, Regulatory, Quality, Medical Affairs, and Market Access to ensure the development and maintenance of a robust safety surveillance
Responsibilities Strategic Leadership and Governance
Continue to evolve and execute the overarching strategy for global PV Operations in alignment with corporate objectives and regulatory expectations.
Establish and maintain the PV system, including quality governance, vendor oversight, and SOP frameworks.
Serve as a senior PV leader within safety governance committees, contributing to safety strategy, risk management, and decision-making.
Partnering with Quality, ensure the organization remains inspection-ready and compliant with global GVP requirements.
Safety Operations Management
Oversee vendors for global case processing (serious and non-serious), data entry, medical coding, quality review, and submission of expedited and periodic reports.
Direct signal management activities, including detection, assessment, documentation, and communication.
Ensure timely and compliant submission of Individual Case Safety Reports (ICSRs), Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and other regulatory deliverables.
Participate in Data Safety Monitoring Board activities, including provision of safety information for DSMB meetings and interim reviews.
Drive continuous improvement of PV workflows, data quality, and operational efficiency.
PV Systems, Technology, and Vendor Oversight
Own the PV system architecture, including safety databases, reporting tools, and technology upgrades.
Oversee vendor selection and management for case processing, literature screening, signal detection tools, and call center services.
Ensure effective performance monitoring, metrics reporting, and issue resolution.
Cross-Functional Collaboration and Communications
Partner with Regulatory Affairs, Clinical Operations and Development, Biometrics, Quality, Medical Affairs, and Market Access to align safety operations with clinical strategy and post-marketing obligations.
Communicate emerging safety issues, operational risks, and compliance gaps to senior leadership.
Partners closely with device manufacturers to ensure appropriate compliance and safety of drug-device combinations.
Requirements Education and Experience
Bachelor’s degree in life sciences; advanced degree (PharmD, RN, MPH, MS, PhD) strongly preferred.
Approximately 15+ years of progressive pharmacovigilance experience in the biotech or pharmaceutical industry, with significant leadership responsibility.
Proven experience establishing or scaling PV operations, including global safety systems and vendor networks.
Prior leadership of major PV regulatory submissions, audits, and health authority inspections.
Experience in both clinical-stage and commercial-stage organizations strongly preferred; drug-device experience important.
Knowledge, Skills, and Abilities
Technical Expertise
Deep understanding of global GVP requirements, FDA and EMA safety regulations, ICH guidelines, risk management planning, and signal detection methodologies.
Expertise with safety databases (e.g., Argus, ArisGlobal, SafetyWorks), case processing workflows, and data quality controls.
Ability to translate complex safety requirements into scalable operational frameworks.
Leadership and Management Skills
Exceptional ability to lead high-performing teams, manage change, and influence senior stakeholders.
Strong vendor management, contract oversight, and operational governance skills.
Ability to manage complex, global workloads with minimal oversight.
Excellent verbal and written communication skills.
Strong analytical, prioritization, and problem‑solving capabilities.
High degree of independence, integrity, sound judgment, and commitment to compliance.
Strong interpersonal skills and the ability to effectively work with other departments and vendors.
Management of other staff, contract service providers, external consultants, and in-house project teams will be required.
Demonstrated aptitude for ‘hands‑on’ troubleshooting and problem solving with an exemplary history as a “self‑starter”.
Unrelenting dedication to defining strategies to support business objectives and delivering high quality results.
Occasional travel required ( Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!
Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
Recruiting Agencies, Please Note
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.
Seniority level
Director
Employment type
Full-time
Liquidia offers medical insurance, vision insurance, 401(k) and other benefits.
#J-18808-Ljbffr
Executive Director, Pharmacovigilance Operations
role at
Liquidia Corporation
1 day ago Be among the first 25 applicants
Direct message the job poster from Liquidia Corporation
Liquidia is deeply passionate and committed to the discovery, engineering, and development required to bring novel therapies to patients who need them most, and to the healthcare providers who care for them. Our current drive is toward improving the treatment of pulmonary hypertension (PH). We will continue to combine our proprietary, innovative PRINT® Technology with new and established medications, offering the potential for both better precision and improved clinical outcomes. Our team members include some of the industry’s top scientists, clinicians, business strategists, engineers, and pharmaceutical executives. We work together to help people lead longer, healthier, and happier lives.
Job Summary The Executive Director, Pharmacovigilance Operations is responsible for building, leading, and overseeing the strategy, systems, and operational execution of global pharmacovigilance activities for pre- and post-marketing programs for Liquidia. Reporting to the Head of Regulatory Affairs and PV, this role ensures that safety operations, case management, compliance oversight, signal management, and safety governance processes meet all global regulatory requirements. The Executive Director will lead a growing PV Operations team, manage PV vendors, and collaborate closely with Clinical Development, Clinical Operations, Regulatory, Quality, Medical Affairs, and Market Access to ensure the development and maintenance of a robust safety surveillance
Responsibilities Strategic Leadership and Governance
Continue to evolve and execute the overarching strategy for global PV Operations in alignment with corporate objectives and regulatory expectations.
Establish and maintain the PV system, including quality governance, vendor oversight, and SOP frameworks.
Serve as a senior PV leader within safety governance committees, contributing to safety strategy, risk management, and decision-making.
Partnering with Quality, ensure the organization remains inspection-ready and compliant with global GVP requirements.
Safety Operations Management
Oversee vendors for global case processing (serious and non-serious), data entry, medical coding, quality review, and submission of expedited and periodic reports.
Direct signal management activities, including detection, assessment, documentation, and communication.
Ensure timely and compliant submission of Individual Case Safety Reports (ICSRs), Development Safety Update Reports (DSURs), Periodic Safety Update Reports (PSURs), and other regulatory deliverables.
Participate in Data Safety Monitoring Board activities, including provision of safety information for DSMB meetings and interim reviews.
Drive continuous improvement of PV workflows, data quality, and operational efficiency.
PV Systems, Technology, and Vendor Oversight
Own the PV system architecture, including safety databases, reporting tools, and technology upgrades.
Oversee vendor selection and management for case processing, literature screening, signal detection tools, and call center services.
Ensure effective performance monitoring, metrics reporting, and issue resolution.
Cross-Functional Collaboration and Communications
Partner with Regulatory Affairs, Clinical Operations and Development, Biometrics, Quality, Medical Affairs, and Market Access to align safety operations with clinical strategy and post-marketing obligations.
Communicate emerging safety issues, operational risks, and compliance gaps to senior leadership.
Partners closely with device manufacturers to ensure appropriate compliance and safety of drug-device combinations.
Requirements Education and Experience
Bachelor’s degree in life sciences; advanced degree (PharmD, RN, MPH, MS, PhD) strongly preferred.
Approximately 15+ years of progressive pharmacovigilance experience in the biotech or pharmaceutical industry, with significant leadership responsibility.
Proven experience establishing or scaling PV operations, including global safety systems and vendor networks.
Prior leadership of major PV regulatory submissions, audits, and health authority inspections.
Experience in both clinical-stage and commercial-stage organizations strongly preferred; drug-device experience important.
Knowledge, Skills, and Abilities
Technical Expertise
Deep understanding of global GVP requirements, FDA and EMA safety regulations, ICH guidelines, risk management planning, and signal detection methodologies.
Expertise with safety databases (e.g., Argus, ArisGlobal, SafetyWorks), case processing workflows, and data quality controls.
Ability to translate complex safety requirements into scalable operational frameworks.
Leadership and Management Skills
Exceptional ability to lead high-performing teams, manage change, and influence senior stakeholders.
Strong vendor management, contract oversight, and operational governance skills.
Ability to manage complex, global workloads with minimal oversight.
Excellent verbal and written communication skills.
Strong analytical, prioritization, and problem‑solving capabilities.
High degree of independence, integrity, sound judgment, and commitment to compliance.
Strong interpersonal skills and the ability to effectively work with other departments and vendors.
Management of other staff, contract service providers, external consultants, and in-house project teams will be required.
Demonstrated aptitude for ‘hands‑on’ troubleshooting and problem solving with an exemplary history as a “self‑starter”.
Unrelenting dedication to defining strategies to support business objectives and delivering high quality results.
Occasional travel required ( Liquidia offers a competitive compensation package (base salary and commission) as well as a comprehensive benefits package that includes Medical, Dental, Vision, STD, LTD, 401(k) Savings Retirement Plan, ESPP, Unlimited Paid Time Off and more!
Liquidia is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. Reasonable accommodation may be made to enable qualified individuals with disabilities to perform the essential functions of this position.
Recruiting Agencies, Please Note
Liquidia will not accept unsolicited assistance from recruiting/search agencies for this employment opportunity. Please, no phone calls or emails. All resumes submitted by recruiting or search agencies to any employee at Liquidia via email, the Internet or in any form and/or method without a valid written search/recruitment agreement in place for this position will be deemed the sole property of Liquidia. No fee will be paid in the event the candidate is hired by Liquidia as a result of the referral or through other means.
Seniority level
Director
Employment type
Full-time
Liquidia offers medical insurance, vision insurance, 401(k) and other benefits.
#J-18808-Ljbffr