Senior Toxicologist & Non-clinical Safety Adviser

Currently, acting as Senior Toxicologist and Nonclinical Safety Advisor at Ferrer Advanced Biotherapeutic. Responsibilities as Manager of Nonclinical Toxicology and Safety issues to support the nonclinical development projects with the aim to obtain new medicinal products. More than 12 years as Nonclinical Toxicologist Expert in the R&D teams scheduling and coordinating the execution of the nonclinical toxicology studies performed in the company facilities or outsourced to CROs according to the highest standards of quality ensuring full compliance with GLP and regulatory requirements. More than 12 years, representing the company and act as point of contact with CROs/suppliers. Monitoring, reviewing/discussing the study protocols and review of the results and approval of the final reports. Nonclinical Toxicologist acting in the preparations of relevant documents for International Medicines Agencies (eg. IMPD, IB, NDA, RMP, PSUR, Scientific Advice). Responsible of review of the Nonclinical Toxicology data included in the dossier for marketing authorization supporting the activity of Regulatory Affairs Department. Preparation and signature of Nonclinical Expert Report for Regulatory Affairs Department during renewal of the marketing authorization dossier. Responsible of preparation/review of the Nonclinical Toxicology data and response presented by the company to the regulatory authorities. During the last 5-years, active experience with European regulators, FDA and Health Canada and other regulatory bodies. Experience acting as Study Director / Collaborator / Manager in more than 50 in vitro and in vivo preclinical toxicological studies. Nonclinical Toxicologist acting in the evaluation of nonclinical safety data during the licensing-in procedures of the company. Experience acquired (6-years) as Nonclinical Toxicologist in Contract Research Organization. Acting as Study Director in charge of design, conduction and preparation of final reports of in vitro and in vivo preclinical toxicological studies. Experience in other areas related with nonclinical safety evaluation such as safety pharmacology, toxicokinetic and bioanalytical methods supporting the nonclinical toxicology studies. Experiences working during 4-years as a Pharmacovigilance Officer/Drug safety in the Scientific Area of Ferrer Internacional S.A. Main responsibilities in several fields of Pharmacovigilance and Cosmetovigilance issues to support the efficacy, safety and well-use of medicines of the company.