Associate Clinical Safety Surveillance Director

Associate Clinical Safety Surveillance Director

Responsibilities

• Oversee management of SAEs and events of special interest across UT sponsored clinical trials; provide strategic direction to team and vendors to improve efficiency, quality, and compliance.
• Support safety governance, inspection readiness, and sustained regulatory compliance for the UT Sponsored Clinical Trial portfolio.
• Evaluate and execute process changes in response to regulatory updates for end-to-end SAE and AESI handling.
• Maintain and monitor unified SAE/AESI handling operating procedures (e.g., Safety Management Plan); ensure processing/submission per UT SOPs and industry standards.
• Provide strategic guidance for developmental PV case management and reporting of ICSSRs.
• Serve as main point of contact for day-to-day questions and issue escalation on SAE/AESI handling; manage GPS clinical trial oversight team metrics.
• Develop and deliver training/materials for SAE/AESI handling; lead direct reports (training, performance, coaching/mentoring, career development, recruitment support as needed).
• Lead inspection/audit readiness; perform root cause analysis and ensure CAPA; review/approve deviations/CAPAs.
• Develop and implement new/revised SOPs; update procedural documents for SAE/AESI case handling.
• Stay current on global/local GCP and GVP regulations supporting clinical trials in PV.

Minimum Requirements

• BS in related field or BSN with 12+ years, or MS with 10+ years, or PharmD/PhD/MD/DO (or international equivalent) with 7+ years in pharmacovigilance end-to-end ICSR case processing.
• 5+ years vendor management and/or CT oversight; 5+ years clinical trial or product development.
• 3+ years people management.
• Argus experience (preferred) and/or other safety databases.
• End-to-end case processing (data entry, QC, medical review, regulatory submissions).
• Project management; drug development and registration safety knowledge; global regulations/guidelines; MedDRA coding; strong written/verbal and analytical skills; cross-functional effectiveness; ability to challenge current state; adaptable in ambiguity.
• Prior clinical PV management experience.

Job Location/Work Schedule

• Durham, NC office with hybrid schedule (at least 3 days in office each week).