Verónica Olivo Pimentel

 Authored of Clinical Evaluation Plans (CEP), Reports (CER), PMCF Plans, and PMCF Evaluation Reports for class I and IIA medical devices in mother & infant care and dermatology fields.  Conducted 50+ medical safety assessments, determining seriousness, device relatedness, and reportability of safety complaints in mother & infant care and dermatological medical devices.  Served as medical safety officer conducting risk management activities (P2 estimations, benefit-risk analyses), health hazard evaluations, and IFU safety precautions/warnings for mother & infant care medical devices.  Authored 5+ systematic literature searches to support State of the Art (SOTA) evaluations, claims substantiation, and clinical development strategies for breastfeeding & infant care medical devices.  Served as Site Coordinator (informed consent process, participants eligibility) for a pre-market clinical investigation in Chicago, US involving an Intense Pulsed Light hair removal device.

 Authored 2 CEPs and CERs for two similar class III implantable medical devices and one class IIB medical device software in the interventional oncology field.  Authored 2 Summary of Safety and Clinical Performance (SSCP), including plain language summaries.  Led the execution and data analysis of Post-Market Surveillance (PMS) and Post-Market Clinical Follow-Up (PMCF) activities for two class III medical devices. Authored 1 PMS/PMCF Plan and 1 PMCF Evaluation Report, and 1 Periodic Safety Update Report (PSUR) based on findings.  Authored the Clinical Investigation Plan and the Investigator's Brochure (IB) for one PMCF study.  Served as medical safety officer for clinical assessments of safety complaints, including root cause analyses, and determination of seriousness, device relatedness, and reportability.  Collaborated with Regulatory Affairs and Product Management, providing medical expertise on 10+ activities related to risk management, product changes, and IFU updates.  Performed 5+ scientific literature searches to support Medical Affairs and HEOR teams, including SOTA evaluations, a synopsis for a clinical study, and a reimbursement application dossier.  Improved PMS and PSUR processes by implementing statistically robust trend analysis and IMDRF coding of 50+ safety complaints, ensuring compliance with art. 88 of EU MDR.

 Published a high-impact article on long-term immunity to mild COVID-19, by analyzing clinical data from 100+ patients, writing and editing the manuscript, and managing the publication strategy.  Authored 10+ internal scientific reports for a project on immunity post-SARS-CoV-2 vaccination, leading data quality assurance and control, project updates, and stakeholder engagement.  Designed training materials and Standard Operating Procedures for the ELISpot technique, enabling high-quality data generation and greater autonomy for junior technicians.