.Senior Manager, PharmacovigilanceICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We have an incredible opportunity for a Senior Manager, Pharmacovigilance (Reporting Group) to join the team.Location: Mexico City (office-based with remote flexibility)Overview of the Role:Manages personnel within Pharmacovigilance and has expertise with regards to the tasks of the subordinated group (E.G. may provide services for Serious Adverse Events (SAE)/Adverse Reactions/Medical Device Report management in writing or by phone, periodic safety reports, adjudication, coding, product complaints). Supports departmental initiatives and development of SOPs, investigation of process-related issues, consulting on safety processes, tools, and regulatory compliance. Maintains familiarity with current industry practices and regulatory requirements that affect services provided by the assigned Pharmacovigilance service area. Ensures that staff fulfill their responsibilities in accordance with company policies, procedures, and SOPs.Supports successful completion of projects on-time, within budget limits and with approved quality levels to support achievement of the department's overall financial and quality goals and objectives. May serve as the main point of contact for the customer for the life-cycle of assigned stand-alone safety and medical information projects, and the main pharmacovigilance point of contact for assigned full-service projects.The role:Monitors projects to assure company profitability and associated project goals and objectives are being met.May serve as the main point of contact for the customer for the life-cycle of assigned stand-alone projects and programs.Develops, implements, and monitors profitability, objectives, metrics of assigned group of direct reports.Identifies and implements improvements of processes within own service area through review of project specific plans and their implementation; recommends improvement plans to projects.Manages resources and resource projections to ensure project teams are consistent with client needs, expectations and contractual obligations.Analyzes current and future project backlog in order to provide adequate resources to meet business objectives.Identifies and implements process improvements and other ways to improve efficiencies.Provides technical oversight of the generation of project plans such as Safety Management Plans (SMP) or SAE Reconciliation plans.Delivers training on department related topics as well as general company processes and systems to Pharmacovigilance staff.Maintains familiarity with current industry practices and regulatory requirements that affect services provided by the assigned service area
