Carolina Vespoli De Melo Email and Phone Number
Carolina Vespoli De Melo is a Patient Safety Partner at Roche Canada | PharmD. at Roche. She possess expertise in management, pesquisa, team building, pharmaceutical industry, sap and 2 more skills.
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Patient Safety PartnerRoche Oct 2022 - PresentMississauga, Ontario, Canada- Partnership with Global and local functions (Medical, Regulatory, Commercial, Access, MedInfo, Patient Services, etc) to advance the patient safety strategy and co-create solutions that improve the lives of patients with SMA, hemophilia, and ophthalmological diseases- Roche Canada's point of contact for the Global team, auditors, and inspectors on the Safety Risk Management Plan (RMP) implementation process- Enhancement of safety information sharing for better-informed treatment decisions by HCPs- Engagement with global affiliates and teams, fostering strong relationships across diverse regions- Vendor oversight (educational materials distribution to patients and HCPs)- Affiliate's digital media Pharmacovigilance co-champion -
Patient Safety Specialist (Part-Time Rotation)Roche Aug 2021 - Oct 2022Mississauga, Ontario, Canada- Affiliate's digital media Pharmacovigilance oversight to ensure compliance with Global requirements and Health Canada's regulations- Safety risk assessment of projects with patients and/or HCPs engagement (non-PSP/Market Research) -
Drug Safety/Pharmacovigilance AnalystRoche Jun 2016 - Oct 2022São Paulo, Brasil- Committed to a patient safety-strategic mindset within the affiliate, ensuring customer-centric approaches in the areas of Oncology, Hemophilia, Neurology, and Specialty Care- Collaboration with cross-functional teams (Safety, Medical, Access, Marketing, Legal & Compliance, Sales, Regulatory, Digital, Communications, etc) at Global and local levels - Pharmacovigilance (PV) training for external HCPs, vendors, and internal teams- Awareness campaigns for external HCPs underscoring the importance of patient safety- Local implementation of safety risk management educational materials (EM) tailored for HCPs, patients, and caregivers based on insights e.g. gathered from Brazil's top Hemophilia Treatment Center's Nursery team; post-implementation feedback gathering aiming for continuous improvement- Assist the Medical Information team in responding to safety queries from HCPs- Triaging and processing of adverse event (AE) reports, including writing narratives and MedDRA coding, and follow-up with reporters (patients and HCPs)- Quality review and submission of AE reports to the local Health Authorities (HA)- Preparation and submission of Aggregate Safety Reports (Addendum PSURs/PBRERs), Global Safety Communications (DHPC and TWIMCL), and Risk Management Plans (RMP) to the local HAs- Oversight and risk assessment of CRM platforms for AE identification- SOPs, PV Business Continuity Plan (BCP), and Local PV System Master File (PSMF) management- Case Transmission Verification (reconciliation)- Local scientific literature screening for AEs- PV quality checks following procedural documents and guidelines- Knowledge of local PV legislation, GVP, and participation in PV audits -
Safety ChampionRoche Jul 2020 - Jun 2022São Paulo, Brazil- Affiliate's representative for the implementation of a Global project's pilot, "Safety in Context", aiming to provide timely, transparent, and contextualized safety information on emicizumab and ocrelizumab, to address patients' and HCPs' medical information inquiries - Interactions with the USA, Canada, Australia, Germany, France affiliates and the Global teams- Interface with different local partners, including customer-facing (MedInfo, Medical, Commercial, and Access), to ensure a successful implementation of the pilot, and share the local needs and insights -
Sales Training And Development InternRoche Apr 2015 - May 2016São Paulo- Support to the Access Training Manager in planning and implementation of sales meetings and onboarding programs- Development of technical-scientific educational materials for Sales and Access teams- Support in the development of a digital training platform focused on Medical and Business Strategy topics for Oncology and Specialty Care franchises -
Undergraduate Student ResearcherUniversidade Estadual Paulista Júlio De Mesquita Filho Jan 2011 - Oct 2014Araraquara- CNPq Scholarships: I) Synthesis, characterization and adsorption in silicon obtained by aerosol spray pyrolysis and sol-gel method II) Use of biocellulose in cosmetic preparations- FAPESP Scholarship: Optimized biocellulose production and the use of Molecular Biology
Carolina Vespoli De Melo Skills
Carolina Vespoli De Melo Education Details
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Pharmd., Pharmacy And Biochemistry -
General English
Frequently Asked Questions about Carolina Vespoli De Melo
What company does Carolina Vespoli De Melo work for?
Carolina Vespoli De Melo works for Roche
What is Carolina Vespoli De Melo's role at the current company?
Carolina Vespoli De Melo's current role is Patient Safety Partner at Roche Canada | PharmD..
What schools did Carolina Vespoli De Melo attend?
Carolina Vespoli De Melo attended Universidade Estadual Paulista Júlio De Mesquita Filho, Delfin English School.
What skills is Carolina Vespoli De Melo known for?
Carolina Vespoli De Melo has skills like Management, Pesquisa, Team Building, Pharmaceutical Industry, Sap, Team Leadership, Gmp.
Who are Carolina Vespoli De Melo's colleagues?
Carolina Vespoli De Melo's colleagues are Liza Sobrera, Natalia K., David Nobbs, Dubraska Lamas, Thet Shwe, Suman Thakur, Maximilian Gugel.
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