Rebeca L. Email & Phone Number

• Handling of SAEs in clinical trials and spontaneous reports from the market, to ensure collection, assessment and entering into the safety database in accordance with the clients’ SOPs and existing demands of the authorities.• Review and approval of processed cases and AE/SAE reconciliation.• Coding, QC and approval of adverse events, medical history and concomitant medication according to MedDRA and WHO-Drug Dictionary.• Review and write the safety section in clinical study protocols.• Review of clinical trial reports/IBs from a safety perspective.• Write the safety parts in the PSUR/PBRER, DSURs, IND, NDA and other safety documents.• Literature searches.• Electronic reporting to EudraVigilance.• Contribute to plans/instructions and SOPs for post approval surveillance.• Updating of templates for safety handling in specific studies/projects according to relevant SOPs.• Provide internal support to other relevant departments.• Validation of computer applications specific for the department with respect to drug safety requirements.• Education and supervision of new Drug Safety personnel.

• Compilation of initial and follow-up information related to Individual Case Safety Reports.• Collaboration in the national and world-wide literature review.• Preparation of PBRER, ASR, risk management plans, ad-hoc safety reports and any other requested document by the regulators.• Elaboration and maintenance of the PBRER annual calendar.• Marketed product labelling activities (SmPC, PIL, CCSI and CSP) (core labelling committee, preparation of labelling assessment reports).• Implementation and updating of SOP and WI required for compliance with the company’s internal and external corporate pharmacovigilance responsibilities, according to the current local and international pharmacovigilance regulation to maintain the pharmacovigilance system.• Writing responses to regulatory safety queries including PBRER assessment reports in collaboration with the medical advisor.• Performing safety signal detection activities for local and corporate marketed products.• Providing material and training on pharmacovigilance and local regulation to new employees, Spanish market company staff, sales force staff and other interrelated departments.• Reviewing and updating of safety agreements with partners, CRO and third-service party providers.• Collaboration in the internal and external audits planning.• Maintenance of the pharmacovigilance archive.

• Systematic weekly national and worldwide literature review to detect individual case safety reports of suspect adverse drug reactions and safety-related information.• Management and submission of suspect adverse drug reaction reports. • Data entry of ICSR in ARISg.• MedDRA and ATC coding of suspect adverse drug reactions, adverse events and medicines.• Electronic submission of ICSR through Gateway.• Management of pharmacovigilance archive.• Preparation of Periodic Safety Update Reports and Expert Reports.• Evaluation and updating of Summary of Product Characteristics, Patient Information Leaflets and Company Core Safety Information documentation.• Preparation of Standard Operational Procedures and Working Instructions to maintain the pharmacovigilance system.• Training to the sales representatives and interrelated departments.• Updating and reviewing of safety agreements.• Collaboration with the internal and external audit program.

• Design and implementation of its pharmacovigilance system, providing consulting services on an on-going basis.• Preparation of Periodic Safety Update Reports and Expert Reports, both in English and Spanish.• On-going review and update of Standard Operational Procedures and Working Instructions for pharmacovigilance.• Training in all pharmacovigilance aspects through practical courses specially designed to meet all customer’s needs, in-house or externally performed.• Audit of the customer pharmacovigilance system, followed by recommendations in order to adapt it to the legislation in force as well as to improve and optimise the resources.• Weekly systematic literature review, with first and second reviews of their outcomes in order to identify the reportable and non-reportable individual cases.• Management of adverse reaction reports (evaluation, coding, data entry into AERS database and follow-up).• MedDRA and ATC coding of adverse drug reaction, adverse events, medical history and medicines.• Electronic reporting to the EMA and European Regulatory Authorities (EVWEB tool).• EudraVigilance Medicinal Product Dictionary (EVMPD).• Writing of Risk Management Plans and Description of the Pharmacovigilance System.• Scientific translations (pharmaceutical dossiers, SOP, WI and any pharmaceutical documentation).

* Ellaboration of magistral formulas.* Sale of medicinal products, herbal medicines and OTC.* Management of prescriptions.* Managements of psycotropic and stupefacients.* Management of the stock.* Pharmaceutical attention.

• Quality control of raw materials and final product. Official methods of fodder analysis.• Microbiological and chemical analysis of water.• Regulation and documentation related to raw material used in animal feeding, composed fodders, additives and corrective substances, medicinal premixtures, animal feed establishments, undesirable substances in animal feed and animal health.• Role of a pharmacist in retail commercial establishments. • Sale of veterinary medicinal products and veterinary consultancy.

* "Evaluation of Health level and Quality of life of intellectual disabled people in Salamanca"* "Evaluation of Cancer Health Education of the population in Salamanca".

Problems, Methods And Topical Issues In Medical Translation.

Director: Fernando A. Navarro 30 hours.

Master'S Degree In Medical And Scientific Translation, Language Interpretation And Translation, 2,23

Itinerario de especialización profesional. - Prácticas profesionales. Trabajo final de máster: Fitzpatrick’s Dermatology in General.

Bachelor Degree, Pharmacy