Associate Director, Pharmacovigilance Operations & Compliance

Liquidia•,

About The Position

The Associate Director, Pharmacovigilance Operations & Compliance is responsible for hands-on operational execution, vendor oversight, and compliance for the company's pharmacovigilance activities across a marketed drug-device combination product and a growing clinical trial portfolio outsourced to multiple CROs. The role owns PV operational deliverables end-to-end, including clinical trial safety operations, aggregate report project management, vendor governance, contracts and budgets, and the PV quality system. It also provides independent second-line review of key deliverables to ensure accuracy, timeliness, and inspection readiness. The Associate Director partners with the PV team and with Regulatory Affairs, Clinical Operations, Quality, Medical Affairs, and Market Access to strengthen operational readiness and consistent execution of the company's pharmacovigilance framework as the portfolio scales. Occasional travel of less than 10% is required.

Requirements

Bachelor's degree in life sciences, pharmacy, or nursing.
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).
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).
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 and 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.
Excellent attention to detail and commitment to accuracy, with a second-line QC mindset.
Ownership and accountability, carrying deliverables through 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%).

Nice To Haves

An advanced degree (PharmD, RN, MPH, or MS).
Experience with drug-device combination products.
Familiarity with ex-US requirements for drug-device combination products under EU MDR 2017/745.

Responsibilities

Serve as the PV operational lead and representative across the clinical trial portfolio, attend trial and safety-governance meetings, and ensure PV requirements are met.
Coordinate study-level Safety Management Plans, safety database and EDC setup, SAE/SUSAR reconciliation, and study startup 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 applicable aggregate reports, including PADERs, PBRERs, DSURs, NDA/IND Annual Reports, and APQRs; coordinate timelines, checklists, data providers, and listings QC.
Support timely and compliant submission of Individual Case Safety Reports and periodic reports in partnership 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 and document 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 under 21 CFR Part 4, including PQC processing, reporting, and reconciliations.
Ensure compliance with global GVP, FDA, and other applicable health authority requirements.
Review and administer PV vendor SOWs, change orders, and budgets; track spend, reconcile invoices, and support contract negotiations.
Provide an independent second-line review of PV deliverables, including aggregate reports, budgets, submissions, and vendor outputs, to ensure accuracy, completeness, and timeliness and reduce single-point-of-failure risk.