Manager Patient Safety & Pharmacogivilance Operations – Contractor

The University of Texas MD Anderson Cancer Center; United States; Remote; USD 85,000 - 125,000; Full time

Job summary

A leading cancer research institution is seeking a Manager for Patient Safety & Pharmacovigilance Operations to oversee safety case processing and vendor management for clinical trials. This contractor role requires strong knowledge of safety regulations and excellent communication skills, offering the opportunity to work in a dynamic, remote environment.

Qualifications

• Minimum 4–6 years’ experience in Clinical Safety Operations.
• Strong knowledge of regulatory guidelines (FDA, EMA, MHRA).
• Oncology experience strongly preferred.

Responsibilities

• Oversee safety vendors and CROs for case processing and safety reporting.
• Ensure timely submission of expedited and aggregate safety reports.
• Perform quality control checks on safety cases and submissions.

Skills

Collaboration

Communication

Organizational Skills

Education

Bachelor’s degree in nursing, pharmacy, or a healthcare-related field

Tools

Argus

MedDRA

QC tools

Document management systems

Job description

Job Title:Manager Patient Safety & Pharmacogivilance Operations – Contractor

Job Number: 36445

Location: Remote,

Job Description

Responsible for managing and overseeing end-to-end safety case processing and reporting activities, in collaboration with external vendors and CROs. This role supports safety operations for clinical trials, ensuring regulatory compliance, high-quality deliverables, and cross-functional alignment.

Responsibilities

• Oversee safety vendors and CROs for case processing and safety reporting activities.

• Review vendor project plans and monitor deliverables to ensure compliance and quality.

• Provide guidance and subject matter expertise for safety operational processes.

• Ensure timely submission of expedited and aggregate safety reports.

• Perform quality control checks on safety cases and submissions.

• Oversee the global safety database, including updates, configurations, and submissions.

• Support data exchange with partners per safety agreements.

• Provide operational support to study teams and participate in safety planning and reconciliation activities.

• Collaborate cross-functionally to ensure inspection readiness and support regulatory filings.

• Assist with audits, inspections, and address any safety compliance issues.

Required Skills

• Bachelor’s degree in nursing, pharmacy, or a healthcare-related field.

• Minimum 4–6 years’ experience in Clinical Safety Operations.

• Strong knowledge of Argus, MedDRA, QC tools, and document management systems.

• Familiarity with FDA, EMA, MHRA, and Asia-Pacific regulations, ICH guidelines, and safety submissions.

• Proven experience in vendor oversight and safety project leadership.

• Excellent collaboration, communication, and organizational skills.

• Oncology experience strongly preferred.