Andres Martinez Email and Phone Number

Partnering closely with Research & Development at Moderna to ensure processes / system changes in Clinical Safety and PV functional areas are managed according to the current standards.

Supporting crossfunctional organizations to achieve high levels of quality and compliance on daily operations as per corporate, global and local regulatory requirements.

Supporting Country Safety Leaders in compliance of regulatory requirements for Pharmacovigilance (PV) activities in LATAM region. Interpretation/ communication of new or changing regulations. Management of investigations, audits/inspections, CAPA development and monitoring and metrics reporting or performing these activities in the absence of a Country Lead.Project management for business initiatives for compliance of local regulations and corporate standards.Management of training of Pharmacovigilance (PV) staff, management of PV procedures, management of contractual partners Adverse Experience exchange agreements.

Responsible of management of the change control and documentation unit for manufacturing, quality assurance and regulatory business projects. Implementation of strategies, plans and projects to comply with local HA requirements to mantain/enhance the product portafolio accordinngly with the local and exporting markets.

Project manager for quality assurance processes as Quality Risk Management, validation of analythical methods, diversion and counterfeit investigations. Promoter of Bussiness Proceess Excellence methofology based on six sigma for the implemenation of project management tools.