Associate Clinical Safety Surveillance Director

Role: Associate Clinical Safety Surveillance Director overseeing SAE and AESI management in clinical trials for innovative therapies targeting rare and life-threatening diseases, including pulmonary and organ transplant indications. Responsibilities: provide strategic direction on global safety surveillance, ensure compliance with GCP and pharmacovigilance regulations, evaluate and improve safety data collection processes, manage safety data systems, lead inspection and audit readiness, develop SOPs, and mentor team members. Serve as the main safety contact for external inspections and internal safety governance. Qualifications: Bachelor’s, Master’s, or PharmD/MD with 7+ to 12+ years in pharmacovigilance, including end-to-end ICSRs processing, vendor management, and clinical trial oversight; experience with Argus or similar databases; strong project management, analytical, and communication skills. High-Value: focus on safety surveillance for early to late-phase clinical trials in biologics, cell/gene therapies, or small molecules; emphasis on rare disease areas such as PAH, pulmonary fibrosis, or organ transplant. Work Setup: hybrid at Durham, NC, with flexible in-office requirements.