Lina Valero

• Responsible for PV in LATAM region
• Protect existing business by minimizing safety risks for patients and consumers.
• Lead and develop the team of Country Safety Heads (CSH) and PV managers.
• Responsible to perform an effective oversight and management of the PV activities delegated to distributors and/or vendors·
• Ensure on time PV deliverables for new product launch, innovation, divestment, switch projects in LATAM region.
• Ensure PV audit and inspection readiness.
• Ensure adequate resources and budget allocation in LATAM region.
• Enable swift communication of product-specific safety and efficacy information among Sanofi functions globally to achieve effective safety risk mitigation and optimization of the benefit-risk profile.
• Ensure full compliance with all global, regional, and local regulatory requirements and company standards for safety data management and reporting, for all registered and in development products as well as in the launch- and post-marketing phases.
• Foster value-adding collaboration with other Sanofi functions on local and regional level, leading -to pragmatic, cross-functionally aligned solutions.
• Ensure that SDEAs with distributors and/or PV agreement with PV vendors are established, maintained, and revised in due timelines. Ensures that all PV activities described in the SDEAs and/or PV agreements are followed to assure ongoing compliance.
• Manage local / regional compliance metrics generation. Ensure compliance with PV key performance metrics (ICSR/PSR submission, timely LcPSMF revision, timely CAPA completion etc.,)
• Ensures documentation of PV process non-compliance to include investigation, Root Cause Analysis (RCA), Corrective Actions/Preventive Actions (CAPAs) implementation and coordinate related tracking activities.
• Ensures that further to PV audit and inspection observations, CAPAs and effectiveness checks have been implemented in close interaction with distributor and/or vendor and with Global / Regional CHC Functions, as required.
• Put successor plan in place for critical position within the team

Important achievements/special recognitions:

• Prepared the LATAM PV region for standalone CHC business to a new company.
• Special recognition on September 2023 (exceed award) for the successful achievement of a complex divestment project in LATAM with tight timelines- Recognition was provided from the LATAM commercial leadership team (GM).
• Establishment and implementation of the new CHC PV system in Central America and Caribbean countries; creation and implementation of the local PV, Medical and Regulatory structure, as well as local SOPs for a complex business model (distribution model).
• Simplification: establishment of one single PV Vendor for LATAM region
• Audits & Inspections (Argentina 2023, Panamá 2023, Chile 2024, Brazil 2024) with cero critical findings
• Leadership of the global PSD strategy (2023)

• Responsible manager for CHC PV activities in Colombia, Perú, Panamá and Ecuador
• Local PV contact for the authorities, accountable for PV inspections and is nominated as local Responsible Person for Pharmacovigilance (RPP/QPPV) for the CHC products where applicable per national regulations
• Key leader for all PV related activities at country level, including but not limited to case management, local safety surveillance, signal detection, risk management and risk mitigation activities, patient support programs and market research programs
• Ensures that local PV activities are performed in compliance with the Global PV policies, as well as global, regional and local PV regulations to warrant safe and appropriate use of CHC products on the market in the assigned countries
• Establishes and maintains a robust and efficient local PV system by ensuring the availability and implementation of proper systems/procedures tools and training
• Work closely with the Affiliates PV Head/Country Manager to ensure adequate resources and budget are allocated
• Builds close and robust relations/collaboration with the in-country partner functions, including but not limited to Medical, Regulatory, Quality, Commercial, Legal, and Country Manager
• Build and maintain robust collaboration/interaction with the in-country partner functions, to carry out and monitor local PV activities, in compliance with PV regulatory requirements and company procedures/guidelines

Important achievements/special recognitions:

• Obtaining the 'Good Pharmacovigilance Practice Certification' from DIGEMID (Perú Health Authority) after outstanding results during local Health Authority Inspection in Perú – 2023
• Establishment and implementation of the new CHC PV system for 4 countries (Colombia, Perú, Panamá y Ecuador)
• Peru´s Challenge in Counterfeit project: worked together with ALAFARPE (Perú Pharma association) and DIGEMID (Perú HA) in the implementation of strategies aimed to reduce illegal drugs trade in the region - 2022
• Successful implementation of E2B e-reporting for marketed products in Perú and Colombia- 2022.
• Successful harmonization of local PV procedures within Hispanic America -2022

• Multi- Country Safety Head Back-up
• Pharmacovigilance expert and advisor
• Knowledge and mastery of the Colombia and Perú safety regulations and international regulations as well as industry standards
• Knowledge of Sanofi global Safety procedures
• Clinical interpretational skills based on limited information with understanding of medical terminology
• Leadership skills such as strategic thinking, decision making, ability to teach and mentor
• Ensure compliance of ICSR processing according with timelines
• Ensure implementation of the global safety procedures in all pharmacovigilance activities
• Ensure process compliance with local PV regulations
• Communication to the global group of PV local regulations updates
• Ensure that quality documents are updated and compliant with local PV regulations and global Sanofi procedures
• Audit and Inspection readiness
• Surveillance of products alerts
• Signal detection activities of local products
• Constant training of the local pharmacovigilance staff (Pharmacovigilance analysts)
• Pharmacovigilance training of Sanofi employees and external third parties working for Sanofi
• Surveillance of ongoing PSPs, ensuring compliance of reconciliation and QC process
• Preparation and presentation of periodic safety reports such as SUSAR, DSUR, PSUR and PBRER
• Preparation and presentation of RMP when requested by Health Authorities
• Ensure that local compliance metrics are generated, and deviations are managed including root cause analysis (RCA) and corrective actions Preventive actions (CAPA)

Important achievements:

- INVIMA (Colombia Health Authority) Inspection with outstanding results (0 findings)- 2019

- As part of the role of local safety officer, 4 Signal Management evaluations were prepared, assessed and completed: preparation of the full Safety Evaluation Reports (SER) and presentation in front of the Signal Management Committee (SMC) for local products in 2021. Special recognition for achieving it within tight timelines.

• Knowledge of local and international regulations in Pharmacovigilance, as well as good clinical practices
• Management of individual case safety reports of marketed products and molecules and products in clinical trials; which are sent to Global PV (through the AEGIS platform) and submitted to the local regulatory authority -INVIMA
• Development of periodic safety reports (bimonthly reports, DSUR, PSUR-PBRER) for its submission to the local regulatory authority -INVIMA
• Periodic review of local literature
• Active participation in signal detection processes and preparation of risk minimization plans
• Management of platforms, databases and tools necessary for processing cases: AEGIS, Oracle, MedDra, AWARE

• General medicine practice
• Primary care
• Pediatric growth and development
• Adult patient’s assessment
• Active participation in the administrative area of the medical center, preparing the guides and documents required by the epidemiological surveillance system, complying with the provisions of the Ministry of Health

• Preparation of reports of adverse events
• Reporting of adverse events of marketed products through the PRIMO platform and to the local regulatory authority -INVIMA-
• Follow up process of SAEs related to commercialized products, according to the stablished timelines
• Prepare bimonthly safety reports for submission to the local regulatory authority -INVIMA-