Gabrielle Rosetti M Alves
About
Gabrielle Rosetti M Alves is from Mississauga, Ontario, Canada. Gabrielle Rosetti works in the following industries: "Hospital & Health Care", and "Pharmaceuticals". Gabrielle Rosetti is currently Business Development Coordinator at Aché Laboratórios Farmacêuticos, located in Guarulhos, São Paulo, Brasil. In Gabrielle Rosetti's previous role as a Specialist in technical documentation - DMF at Aché Laboratórios Farmacêuticos, Gabrielle Rosetti worked in Guarulhos until Jun 2021. Prior to joining Aché Laboratórios Farmacêuticos, Gabrielle Rosetti was a Technical regulatory documentation analyst at Sandoz and held the position of Technical regulatory documentation analyst at São Paulo. Prior to that, Gabrielle Rosetti was a Junior Research Analyst at EMS, based in Hortolândia from Mar 2016 to Apr 2017. Gabrielle Rosetti started working as Estagiário at Aché Laboratórios Farmacêuticos in Guarulhos in Apr 2013. From Jul 2012 to Sep 2012, Gabrielle Rosetti was Clinical Pharmacy intern at NewYork-Presbyterian Hospital, based in Brooklyn.
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Gabrielle Rosetti M Alves's current jobs
Gabrielle Rosetti M Alves's past jobs
Organizer and control all activities of the DMF team regarding new applications; Chair meetings to choose API manufacturer partners for all the new applications; Chair meetings of decision-making regarding API manufacturer impacts in the application project; Participate in collegiate meeting regarding feasibility of new projects; Participate in collegiate meeting regarding new application projects; Participate in collegiate meetings regarding launches Focal point of new applications projects Focal point for CTD regulation and implementation; Focal por for RDC 318/2019 (stability); Focal point for Brazilian new regulations for API manufacturer
Participate in project monitoring meetings along with partner or global headquarters; Evaluation of the technical documentation of the manufacturer of API, the DMF; Guide API manufacturer regarding Brazilian regulations and DMF adequacy, either via conference call or via gap assessment; Guide the drug product manufacturer on the quality control of the API; Evaluate technical documentation of the drug product manufacturer regarding the API quality control; Evaluate the drug product manufacturer technical documentation regarding its quality control; Guide the drug product manufacturer regarding the Brazilian regulation for suitability of the dossier to ANVISA´s regulation, either via conference call or via gap assessment; Respond to ANVISA´s deficiency letters; Evaluate forced degradation studies.
Complete analysis of DMFs for new application and post-approval application of drug products according the Brazilian regulations and ICH guidelines. Including specifications, characterization, stability and method validations. Responsible for responding ANVISA´s deficiency letters regarding DMF.
Meeting the scientific demand coming from different departments of the company through bibliographic research of clinical, pre-clinical studies and reviews in different databases (Pubmed, Micromedex, Lilacs, ScienceDirect and Cochrane). Interface with Regulatory Affairs: scientific support and preparation of clinical reports for applications and renewals of registers with ANVISA. Interface with Pharmacovigilance: scientific subsidy referring to new adverse reactions, adverse events or alerts on drug products for the edition of a periodic report sent to ANVISA; Interface with Marketing: support for claims promotional materials directed to health professionals; correction and location of bibliographic references of several promotional materials; elaboration of claims from scientific literature for the development of medical material. Interface with Medical Nucleus, Research and Development, New Business Development, Pharmaceutical Development and Clinical Research. Answering requests for medical-scientific inquiries from health professionals and sales representatives via the Call Center and via the Medical Information channel. I assist in the preparation of clinical reports sent to Anvisa for applications and renewals of drug products.
Trainee in the area of Clinical Pharmacy in neonatal, surgical, medical ICU, psychiatric ward, infection control, medical clinic and chemotherapy. Experienced the Joint Comittion accreditation of this hospital. The internship included evaluation and monitoring of the laboratory results of hospitalized patients and evaluation of the prescribed drugs products in terms of dosage, pharmaceutical form and route of administration. Pharmaceutical interventions were proposed to the multidisciplinary team during the rounds.