Background <p>Robust pharmacovigilance (PV) systems are essential to ensure medicine safety and detect adverse drug reactions. Though established, Nigeria's PV system faces various challenges that need addressing.</p> Objective <p>To examine the current state of pharmacovigilance in Nigeria, focusing on key enablers, barriers, and potential strategies for system strengthening through stakeholder engagement.</p> Methods <p>A three-day stakeholder workshop in March 2024 used a qualitative participatory engagement approach to collect information. The workshop included 23 participants representing diverse organisations, including the Federal Ministry of Health, the National Agency for Food and Drug Administration and Control, healthcare boards, academic institutions, and patient interest groups. Workshop discussions were analysed using hybrid thematic analysis combining inductive and deductive approaches.</p> Results <p>The analysis revealed factors affecting pharmacovigilance at system, organisational, professional, and individual levels. Key enablers included a decentralised structure, the Med Safety App, and existing policies. Barriers included insufficient training and resources, regulatory inertia, poor implementation strategies, limited data availability, lack of stakeholder awareness, and inadequate communication systems. The study developed an integrated framework for system strengthening, which included capacity building, communication enhancement, structural improvements, and success metrics.</p> Conclusion <p>While Nigeria's pharmacovigilance system shows promise through existing enablers, significant gaps persist. Strengthening the system requires a coordinated strategy that capitalises on existing strengths while systematically addressing weaknesses through evidence-based interventions. Success depends on sustained commitment, adequate resources, and effective stakeholder coordination.</p>