Patient Safety & Pharmacovigilance Case Management Operations Lead

Role: Patient Safety & Pharmacovigilance (PSPV) Case Management Operations Lead, overseeing global safety operations for clinical and post-marketing phases. Responsibilities: provide strategic leadership, develop safety systems and processes, manage vendors and cross-functional teams, ensure compliance with global regulations, and lead inspection readiness. Core duties include oversight of ICSR management, safety reporting, regulatory submissions (e.g., DSURs, PBRERs), and safety database optimization. Qualifications: 12+ years in pharmacovigilance within biopharma, with at least 5 years in leadership; degree in healthcare or related field preferred. High-Value: extensive knowledge of global PV regulations (ICH, GVP, FDA, EMA), experience with safety database systems (e.g., Argus), and leading regulatory audits. Collaboration with Clinical Development, Medical Affairs, Regulatory, and Quality teams is essential. The role requires strategic and operational expertise in a global, fast-paced environment, with a focus on organizational transformation, compliance, and continuous improvement.