PV Compliance Lead — Frontline & QA Excellence

AssistRx, Inc.; Orlando (FL); On-site; USD 111,000 - 139,000; Full time

Job summary

AssistRx, Inc. is seeking a seasoned PV Specialist to support the PV manager in frontline operations, including adverse events, product quality complaints, and medical inquiries, ensuring timely reporting and regulatory adherence.

Collaborate with QA, Patient Solutions, Operations, and Compliance to maintain audit-ready PV systems and drive continuous improvement. Requires a bachelor’s in life sciences and 7+ years in pharmacovigilance with 3+ years in a compliance/quality role.

Qualifications

• 7+ years of experience in pharmacovigilance/drug safety.
• 3+ years in a compliance, oversight, or quality-driven role.
• Strong knowledge of global PV regulations, including ICH guidelines and GVP Modules.
• Experience with health authority inspections (DEA, State Board of Pharmacy, URAC/ACHC, OIG, etc.) and audit readiness.
• Biopharmaceutical or biotech experience preferred.
• Certification in pharmacovigilance or compliance preferred.
• Familiarity with PV databases and safety signal detection tools preferred.

Responsibilities

• Drive PV compliance activities to meet global regulatory requirements and integration with QA and Patient Solutions.
• Develop, implement, and manage PV compliance frameworks, SOPs, processes, and systems for drug safety reporting.
• Collaborate with cross-functional teams to enable a patient-centered PV compliance approach.
• Ensure PV systems are audit-ready and support regulatory inspections.
• Assess PV risk and address compliance gaps with QA and Patient Solutions.
• Monitor regulatory changes and inform stakeholders.
• Oversee performance of internal and external resources and report to senior management.
• Support PV audits of partners and service providers and communicate findings.
• Contribute to PV training materials for frontline teams.
• Facilitate preparation and submission of regulatory PV filings and risk management plans.
• Assist with CAPAs and continuous improvement initiatives.
• Engage in program enhancements and associated training for AE, PQC, and MI handling.

Skills

Pharmacovigilance

Regulatory knowledge

Stakeholder management

Quality improvement

Education

Bachelor’s degree in Life Sciences

Tools

PV databases

Safety signal tools

Job description

AssistRx, Inc. is seeking a seasoned PV Specialist to support the PV manager in frontline operations, including adverse events, product quality complaints, and medical inquiries, ensuring timely reporting and regulatory adherence.

Collaborate with QA, Patient Solutions, Operations, and Compliance to maintain audit-ready PV systems and drive continuous improvement. Requires a bachelor’s in life sciences and 7+ years in pharmacovigilance with 3+ years in a compliance/quality role.