Claudia Jiménez

LATAM Pharmacovigilance (PV) Manager - ultragenyx - Mexico

(2025-06 - 2026-05)

Acted as Mexico Responsible PV Person, maintaining continuous and permanent availability to COFEPRIS.
Supported the establishment and ongoing maintenance of local PV system and LATAM to ensure compliance with global and local regulatory requirements.
Contributed to the development and regular update of the México PV System Manual, local Standard Operational Procedures (SOPs), and LATAM PV procedures.
Ensured effective implementation and routine testing of business continuity and disaster recovery plans.
Managed timely and accurate submissions to regulatory authorities, including ICSRs and aggregate safety reports.
Conducted and maintained local non-indexed literature searches and regulatory intelligence for LATAM markets.
Supported preparation of Periodic Benefit-Risk Evaluation Reports (PBRERs), Risk Management Plans (RMPs), and implementation of local risk minimization measures.
Oversaw PV-related activities from local Call Centers and Patient Support Programs (PSPs); provided training in AE/SSE reporting to internal and external stakeholders.
Collaborated in local audit and inspection readiness, including deviation management and CAPA implementation.

Quality, Pharmacovigilance and Technovigilance Coordinator - PINT PHARMA - Mexico

(2020-09 - 2025-06)

Coordination and execution of local activities in accordance with the requirements of NOM-059-SSA-2015, NOM-220-SSA1-2016 and NOM-240-SSA1-2012.
Responsible of Pharmacovigilance and Technovigilance.
Collaboration in Quality activities in PV for the LATAM region, including audits, generation and monitoring of corrective and preventive action plans (CAPAs).
Auxiliar of Qualified person. COFEPRIS/ Audits.
Creation and implementation of the Quality Management System.
Development, modification and/or updating of Standard Operating Procedures.
Training.
Control and safeguarding of documents.
Creation and submission of documentation to COFEPRIS.
Case processing and notification on the COFEPRIS platform.
Management of documents to the authority (authorized person).
Working with suppliers.

Pharmacovigilance, Quality & Regulatory Coordinator - Janssen - Central America

(2016-10 - 2020-02)

Regulatory and Sanitary Responsible (position covered temporarily).
Responsible of Pharmacovigilance.
Collaboration in Regulatory, Quality and Pharmacovigilance activities in 15 Central American countries.
Implementation and management of the Documentary System.
Coordination and execution of local activities in accordance with the requirements of NOM-220-SSA1-2016.
Case processing and notification on the COFEPRIS platform.
Training.
Promotional Materials Coordinator.
Management of documents to the authority (authorized person).
Working with suppliers.

Research & Development Engineer - Kraft Foods / Mondelēz - Mexico

(2011 - 2016)

Update raw material, finished product and formula specifications under Mexican regulation. Generate technical documents. Shelf life of products. Pilot plant and plant tests. Contact with suppliers. Productivity projects.

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