Associate Director, Pharmacovigilance Operations – Compliance

Liquidia Corporation

. Serve as the PV operational lead and representative across the clinical trial portfolio, attending trial and safety-governance meetings and ensuring PV requirements are met.

Posted 10/30/2026full-timeRemote • United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in pharmacovigilance operations, including vendor oversight, aggregate report management, and compliance with global safety regulations. Proficient in managing safety databases and ensuring high-quality deliverables in a fast-paced environment.

Highest-signal resume keywords

Pharmacovigilance ExperienceVendor OversightAggregate Report ManagementSafety Database OperationsRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

PharmacovigilanceAggregate ReportingCase Processing WorkflowsSafety Documentation StandardsRegulatory InspectionsICH GuidelinesEU GVPUS Safety Reporting RegulationsMedDRA CodingDrug-Device Combination Product Experience

Soft Skills

Project ManagementCommunication SkillsCollaboration SkillsAttention to DetailAnalytical Skills

Tools & Technologies

ArgusArisGlobalSafety DatabasesPV Operational Systems

Certifications & Qualifications

Bachelor's Degree in Life SciencesPharmacy DegreeNursing DegreeAdvanced Degree (PharmD, RN, MPH, MS)

Industry Keywords

BiotechPharmaceutical IndustryClinical TrialsPost-Marketing SafetySOP Development

About the role

Key responsibilities & impact

Serve as the PV operational lead and representative across the clinical trial portfolio, attending trial and safety-governance meetings and ensuring PV requirements are met.
Coordinate study-level Safety Management Plans (SMPs), safety database and EDC set-up, SAE/SUSAR reconciliation, and study start-up and amendment activities with CROs and cross-functional teams.
Track and drive PV deliverables, timelines, and action items across all studies.
Manage the end-to-end schedule and delivery of aggregate reports, including PADERs, PBRERs, DSURs, NDA/IND Annual Reports, and APQRs.
Support timely and compliant submission of Individual Case Safety Reports (ICSRs) and periodic reports with vendors and Regulatory Affairs.
Provide day-to-day operational oversight of outsourced PV vendors across case processing, follow-up, reconciliation, signal, and aggregate activities.
Own vendor KPIs, quality metrics, and service-level adherence; prepare governance meetings; and drive deviations and CAPAs to closure.
Oversee high-volume case intake for operational quality and compliance.
Build and maintain the PV quality framework, including SOPs, work instructions, RACI, process maps, training matrix, and metrics governance.
Partner with Quality to maintain audit and inspection readiness, including documentation, SOP development, and CAPA management.
Support compliance for the drug-device combination product, including malfunction and combination-product reporting obligations, PQC processing, reporting, and reconciliations.
Ensure compliance with global GVP, FDA, and other applicable health authority requirements.
Review and administer SOWs, change orders, and budgets for PV vendors; track spend, reconcile invoices, and support contract negotiations.
Provide independent second-line review of PV deliverables, aggregate reports, budgets, submissions, and vendor outputs to ensure accuracy, completeness, and timeliness.

Requirements

What you’ll need

Bachelor's degree in life sciences, pharmacy, or nursing; advanced degree (PharmD, RN, MPH, MS) a plus.
Approximately 8+ years of pharmacovigilance experience in the biotech or pharmaceutical industry, spanning both post-marketing and clinical-trial safety.
Demonstrated ability to own PV operational deliverables end-to-end with minimal oversight.
Strong background in vendor/CRO oversight, aggregate report management (PADER/DSUR), and safety database operations (e.g., Argus).
Experience supporting regulatory inspections and audits; drug-device combination product experience preferred.
Thorough understanding of ICH guidelines, EU GVP, and US safety reporting regulations (21 CFR 314.80 and 312.32; combination-product reporting under 21 CFR Part 4 and device reporting under 21 CFR Part 803).
Familiarity with ex-US requirements for drug-device combination products under EU MDR 2017/745.
Proficiency with safety databases (e.g., Argus, ArisGlobal), case processing workflows, PV operational systems, and MedDRA coding.
Strong command of aggregate reporting, reconciliation, and safety documentation standards.
Excellent project management skills with the ability to manage multiple concurrent deliverables and deadlines.
Strong communication and collaboration skills across functions and with external partners.
Ability to represent PV effectively in cross-functional and trial-governance forums.
Excellent attention to detail and commitment to accuracy, with a second-line QC mindset.
Strong analytical and organizational skills.
Ability to work in a fast-paced environment with evolving priorities.
High degree of independence, integrity, sound judgment, and commitment to compliance.
Occasional travel required (<10%).

Benefits

Comp & perks

Medical insurance
Dental insurance
Vision insurance
Short-term disability (STD)
Long-term disability (LTD)
401(k) Savings Retirement Plan
Employee Stock Purchase Plan (ESPP)
Competitive compensation package
Reasonable accommodation for qualified individuals with disabilities