Description
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.
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.
Requirements
Education and Experience:
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.
- 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.
- 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.
- 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%).