Senior Pharmacovigilance Compliance Lead

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

Job summary

AssistRx, Inc. is seeking a senior Pharmacovigilance professional to support the PV Manager in frontline operations, ensuring safe and compliant handling of AE, PQC, and MI data. You will collaborate with QA, Patient Solutions, Operations, and clients to maintain audit readiness.

The role emphasizes global regulatory compliance, safety reporting, and continuous PV process improvements, with a focus on drug safety across diverse sites and teams.

Qualifications

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

Responsibilities

• Support PV compliance activities to meet global regulatory requirements and industry standards.
• Assist in developing, implementing, and managing PV compliance frameworks, SOPs, and processes.
• Collaborate with cross-functional teams to enable patient-centered PV operations.
• Prepare for regulatory inspections and support audit readiness.
• Identify and address compliance gaps; contribute to CAPAs as needed.

Skills

Pharmacovigilance

Compliance Oversight

Quality Management

Stakeholder Management

Regulatory Knowledge

Education

Bachelor’s degree in a scientific discipline

Tools

PV databases

Safety signal detection

Job description

AssistRx, Inc. is seeking a senior Pharmacovigilance professional to support the PV Manager in frontline operations, ensuring safe and compliant handling of AE, PQC, and MI data. You will collaborate with QA, Patient Solutions, Operations, and clients to maintain audit readiness.

The role emphasizes global regulatory compliance, safety reporting, and continuous PV process improvements, with a focus on drug safety across diverse sites and teams.