Associate Director, Global Clinical Safety & Data Quality

AbbVie; United States; On-site; USD 140,000 - 190,000; Full time

Job summary

AbbVie is seeking a Clinical Trial Patient Safety leader to oversee world-wide safety data review and ensure timely, compliant reporting. You will coordinate with medical monitors and regulatory teams to drive high-quality safety assessments across studies.

The role focuses on process improvement, SOP development, and staff development within a dynamic CTPS organization, with a strong emphasis on collaboration and data integrity.

Qualifications

• Knowledge of ICH, FDA and EMA regulations affecting drug safety.

Responsibilities

• Oversee world-wide surveillance of clinical trial patient safety data to ensure timely and compliant reporting.
• Establish workload projections and metrics for safety operations.
• Lead staff development and training within the CTPS team.
• Partner with medical monitors to provide oversight of safety reviews at study level.
• Improve SOPs and implement new regulatory requirements.
• Coordinate with clinical, regulatory and pharmacovigilance counterparts.
• Manage 5 to 10 staff and support strategic planning.
• Ensure inspection-ready outputs and effective data review processes.

Job description

AbbVie is seeking a Clinical Trial Patient Safety leader to oversee world-wide safety data review and ensure timely, compliant reporting. You will coordinate with medical monitors and regulatory teams to drive high-quality safety assessments across studies.

The role focuses on process improvement, SOP development, and staff development within a dynamic CTPS organization, with a strong emphasis on collaboration and data integrity.