Senior Pharmacovigilance Compliance Lead

AssistRx

Orlando (FL)

On-site

USD 111,000 - 139,000

Full time

2 days ago

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Job summary

AssistRx is seeking a seasoned Pharmacovigilance professional to support PV compliance activities, including regulatory reporting, risk management, and inspections. You will work with QA, Patient Solutions, and Operations to ensure audit readiness and CAPA execution.

The role requires 7+ years in pharmacovigilance with 3+ years in a compliance/quality role, ICH/GVP knowledge, and strong collaboration and communication skills.

Qualifications

Bachelor’s degree in a scientific discipline required.
7+ years in pharmacovigilance/drug safety with 3+ years in a compliance/quality role.
Strong knowledge of ICH guidelines and GVP Modules.
Experience with health authority inspections and audit readiness.
Biopharma/biotech experience preferred; PV certification preferred.

Responsibilities

Support PV compliance activities to meet regulatory requirements.
Collaborate with QA, Operations, and Patient Solutions to manage PV frameworks.
Assist with regulatory filings, audits, and CAPA implementations.
Develop PV training materials and assist in inspections preparation.
Monitor regulatory changes and communicate impact to stakeholders.

Skills

PV regulatory knowledge

Audit readiness

Project management

Cross-functional collaboration

Leadership

Communication skills

Stakeholder management

Quality reporting

Education

Bachelor's degree in Pharmacy or Life Sciences

PV/compliance certification (preferred)

Tools

PV databases

Safety signal detection tools

Job description

The role requires 7+ years in pharmacovigilance with 3+ years in a compliance/quality role, ICH/GVP knowledge, and strong collaboration and communication skills.

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