Giselia Alcantara

Scientific and Medical Affairs Specialist @Kora Healthcare

Dublin, IE

Compile clinical reporting deliverables for medical devices including Clinical Evaluation and Post Market Surveillance.• Provide internal training and specialist support on Brand / Therapy Area for head office and field-based teams as require• Interpret, evaluate, summarise and incorporate clinical evidence from various sources including literature, clinical data, and medical references. Analyses results in preparation for product applications and submissions.• Responsible for conducting medical review and approval (where appropriate) of marketing materials• Ensure compliance to applicable regulations and guidance’s (e.g, ISO 13485, ISO 10993, ISO 14155, ISO 14791, MDR and other EU and FDA guidance documents). Medical Information (MI):• Responsible for intake, escalation, and completion of MI enquiries. Provide high quality, balanced, accurate, up-to-date, constructive and non-promotional scientific information relating to licensed and unlicensed products and indications following unsolicited requests from HCPs patients, health care professionals (HCPs), commercial partners and other stakeholders. Liaising with the Company Medical Advisor and Medical Director as required.• Identify adverse events and product complaints during interactions. Manage this in line with internal company procedures. Participate in reconciliation activities. • Document all customer interactions and medical communication accurately in the medical information database.• Train company staff and external contractors or consultants on Medical Information Procedures

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CPD Certificate

Atlantic Technological University

Higher National Diploma

Universidade Federal Rural da Amazônia

Bachelor's degree

Universidade do Porto

Master's degree

Universidade Castelo Branco - UCB

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