Luis Diego Zúñiga Rojas

Consultation in primary health in the community of Palmares, Alajuela. Reviewing expired medicines, as well as the inventory of existing products.

Corrective Actions Preventive Actions (CAPA) CAC Project. Leaflet review as part of a CAPA process to ensure that the countries are complying according to the leaflets approved by the Authorities of Health.

• (December 2016 - March 2017): Artwork Remediation CAC Project. SKU reviews as part of a Supply process to compile the implementation codes, local code, and the creation of new Pfizer artworks changes.
• (March 2017- October 2019): Viewpoint Remediation CAC Project. Updating the new estimated submission and approval dates with the respective evidence for Planning and Monitoring reports. LENC-LEA Project. Making the changes of the legal entity for the holder license, packager and manufacturer for Illertissen (Germany) and Amboise (France) plants.
• (March 2017 - October 2019): PEARL remediation project. Management global and local systems for tracking submission, queries and approvals procedures in different health authorities of the region: Costa Rica, Panamá, Nicaragua, Honduras, El Salvador, Guatemala, Dominican Republic, Jamaica, Trinidad & Tobago, Aruba, Curacao, Guyana, Haiti and Suriname.

• (October 2019 - Present): Processing of fatal, serious, non-serious and invalid cases in Book-in, Data Entry and Peer Review roles for different countries as Austria, Canada, Mexico, Panama, and Argentina. Participation in action item process as case closure, Non-Significant Follow-Up and DSS notification, NCS notification, DCA Follow-up, PQC error.
• (December 2020 - December 2023):Collaboration with the Continuous Training Team (CTT) and Quality Team to reinforce the updates of guidelines with other colleagues of the HUB AMER Platform.
• (February 2021 - Present): Creation of several excel spreadsheet tools to optimize and facilitate the Data Entry and Peer Review processes using standard statements and generating templates for narrative, contact logs and Action item according with KBs, WI and HEPTA teams updates. The tools were implemented for Mexico, Panama and Canada.
• (August 2021 – June 2023): Teamwork with the Drug Safety Unit (DSU) Platform Poland, DSU-Platform Wuhan and PSSR SME team to identify potential serious upgrade cases during COVID pandemic for Parking lot prioritization using Spotfire dashboard.
• (September 2021 - Present): PV Monitor SME for HUB AMER Platform: Review, analysis, and assessment of cases submission compliance to health authorities, tracking reasons for lateness per metric submission, management of action plans for late cases according to their internal timelines, corrective and preventive actions and root causes.
• (March 2023 - Present): Coordination of the Data Entry and Peer Review processes in Canada, assignment of cases according to their priority, periodic revision of the worklist and update of the assignment list, resolution of requests via email of the Drug Safety Unit of Canada.