Analista de Farmacovigilância Sr

Review and process individual safety reports from company territories, focusing on compliance and quality checks. Evaluate adverse events by coding, analyzing causality, severity, predictability, and benefit-risk profiles. Support risk management activities, including signal detection, monitoring, and risk minimization measures. Draft regulatory documents such as Safety Aggregated Reports, Risk Management Plans, and safety communications. Ensure safety compliance for sponsored and investigator-initiated clinical studies. Participate in global regulatory audits and inspections to maintain area conformity. Implement and maintain the Farmacovigilance Quality Management System, tracking indicators and managing deviations. Harmonize global procedures, policies, and processes. Support safety agreement negotiations, due diligence, and partner management. Evaluate vendors and specialized consulting firms. Deliver technical training to affiliates and interface areas. Lead or contribute to continuous improvement and process transformation projects. Propose label updates and regulatory actions based on new safety information. Provide technical support for global regulatory requirements regarding product safety.