Manager Patient Safety & Pharmacogivilance Operations – Contractor

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.