JUAN DAVID SERRANO VAZQUEZ

• As a Safety Data Lead (SDL) I’m responsible for the analysis and interpretation of adverse experience (AE) reports of varying complexity, in compliance with regulatory requirements and internal processes. Moreover, I execute AE case management activities for both investigational and marketed products in accordance with specific oncology therapeutic area standards, taking into account that the collaboration with internal and external stakeholders is essential to maintain high quality and timely execution of the processes.

• As a Safety Data Specialist (SDS) I was in charge of processing adverse events (AE) information in the global safety system for investigative and/or marketed products, under the direction and supervision of a Global Pharmacovigilance Case Management (GPVCM) Manager. Also, I was responsible for perform triage, analysis and interpretation of AE data following the Company Standard Operating Procedures (SOPs) and guidelines. As a SDS, I understood the importance of high quality and compliant AE case management maintaining a clear perception of case processes, in adherence to corporate policies and following the company’s ways of working, including leadership behaviors.

• Contribute to the maintenance and improvement of the mandatory institutional quality assurance system, in the components of the single qualification system, audit for quality improvement, single accreditation system, and information system, as well as conduct advisory visits, technical assistance, monitoring and evaluation of public, private and pediatric vaccination institutions, verification of
  the interruption of the cold chain, information systems, tracking of programmatic errors, reporting and monitoring of adverse events in pharmacovigilance and techno vigilance, consolidation and analysis of cases.

Develop strategies for maintaining and improving the axes of the single accreditation system: risk management, humanization of care, cultural transformation, excellent and safe clinical management, technology management, user-centered care, and social responsibility. Additionally, carry out the request, distribution, follow-up, consolidation, and report of biological, and medical devices and supplies, according to the need of the program, and carry out the shift mesh assignment and personnel management.