Associate Director, Pharmacovigilance Operations & Compliance

Liquidia Technologies; United States; Sur place; USD 150 000 - 210 000; Plein temps

Résumé du poste

Liquidia Technologies is seeking an Associate Director to lead pharmacovigilance operations and ensure compliance across marketed products and clinical trials. The role focuses on end-to-end PV execution, vendor oversight, and quality system governance.

You will collaborate with Regulatory Affairs, Clinical Operations, Quality, and Medical Affairs to maintain inspection readiness and data integrity in a fast-paced environment.

Qualifications

• Bachelor-level life sciences, pharmacy, or nursing; advanced degree preferred.
• 8+ years pharmacovigilance in biotech/pharma, post-marketing and clinical safety.
• Experience owning PV deliverables end-to-end with minimal oversight.
• Strong vendor/CRO oversight, aggregate reporting, and safety databases.

Responsabilités

• Serve as PV operations lead across the clinical trial portfolio and governance meetings.
• Coordinate Safety Management Plans, safety database setup, SAE/SUSAR reconciliation.
• Track PV deliverables, timelines, and action items across all studies.
• Manage aggregate reports (PADERs, DSURs) and regulatory submissions with vendors.

Connaissances

PV operations

Vendor oversight

Regulatory inspections

Project management

Cross-functional collaboration

Formation

Bachelor's in life sciences/pharmacy/nursing

Advanced degree (PharmD, RN, MPH, MS) a plus

Outils

Argus

ArisGlobal

MedDRA

Description du poste

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.
The Associate Director, Pharmacovigilance Operations & Compliance is responsible for the hands‑on operational execution, vendor oversight, and compliance of the company's pharmacovigilance activities across a marketed drug‑device combination product and a growing clinical trial portfolio outsourced to multiple CROs. This role owns PV operational deliverables end‑to‑end: clinical trial safety operations, aggregate report project management, vendor governance, contracts and budgets, and the PV quality system, and provides an independent second‑line review of key deliverables to ensure accuracy, timeliness, and inspection readiness. The Associate Director partners closely with the PV team, and with Regulatory Affairs, Clinical Operations, Quality, Medical Affairs, and Market Access to strengthen operational readiness and the consistent execution of the company's pharmacovigilance framework as the portfolio scales.

Education and Experience:

• 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.

Knowledge, Skills, and Abilities:

1. Technical Knowledge
   • 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.
2. Project Management and Interpersonal Skills
   • Excellent project management skills with the ability to manage multiple concurrent deliverables and deadlines across a growing portfolio.
   • Strong communication and collaboration skills across functions and with external partners.
   • Ability to represent PV effectively in cross‑functional and trial‑governance forums.
3. Professional Competencies
   • Excellent attention to detail and commitment to accuracy, with a second‑line QC mindset.
   • Ownership and accountability: carries deliverables to completion.
   • 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%).

Clinical Trial Safety Operations:

• 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.

Aggregate Reporting and Regulatory Deliverables:

• Manage the end‑to‑end schedule and delivery of applicable aggregate reports (PADERs, PBRERs, DSURs, NDA/IND Annual Reports, APQRs) including timelines, checklists, data‑provider coordination, and listings QC.
• Support timely and compliant submission of Individual Case Safety Reports (ICSRs) and periodic reports in partnership with vendors and Regulatory Affairs.

Vendor Oversight and Governance:

• 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 and document governance meetings; drive deviations and CAPAs to closure.
• Oversee high‑volume case intake for operational quality and compliance.

Compliance, Quality Systems, and Inspection Readiness:

• Build and maintain the PV quality framework: 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 (21 CFR Part 4), including PQC processing, reporting, and reconciliations.
• Ensure compliance with global GVP, FDA, and other applicable health authority requirements.

Contracts, Budgets, and Independent Oversight:

• Review and administer SOWs, change orders, and budgets for PV vendors; track spend, reconcile invoices, and support contract negotiations.
• Provide an independent second‑line review of PV deliverables — aggregate reports, budgets, submissions, and vendor outputs — to ensure accuracy, completeness, and timeliness and to reduce single‑point‑of‑failure risk.