Associate Director, Pharmacovigilance Operations – Compliance

🔥 16 hours ago

🇺🇸 United States – Remote

⏰ Full Time

🟠 Senior

🧪 Clinical Research

👻 Ghost score 10%

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Liquidia Corporation

WebsiteLinkedInAll Job Openings

51 - 200 employees

Founded 2004

🧬 Biotechnology

💊 Pharmaceuticals

💰 $75M Post IPO equity on 2024-02

Biotechnology • Pharmaceuticals

Liquidia is a biopharmaceutical company focused on developing inhaled therapies for rare cardiopulmonary diseases, particularly pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The company leverages its proprietary PRINT® particle engineering technology to create proprietary formulations and delivery methods aimed at improving efficacy, tolerability, and convenience of inhaled medicines; its pipeline includes inhaled treprostinil (commercial product) and clinical-stage candidates such as L606. Liquidia emphasizes patient support, clinical development, and advancing therapies for improved respiratory outcomes.

📋 Description

• 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

• 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

• 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

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