Pharmacovigilance Operations Lead & Compliance Strategist

Liquidia Technologies; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

PV operations

Vendor oversight

Regulatory inspections

Project management

Cross-functional collaboration

Education

Bachelor's in life sciences/pharmacy/nursing

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

Tools

Argus

ArisGlobal

MedDRA

Job description

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.