Summary profile: -PVpharm-Pharmacovigilance Services for the Pharmaceutical Industry CEO -M.Sc. Pharmacy and M.Sc. IT with international experience in Pharmacovigilance at the industry and the government (Danish Medicines Agency). -Excellent communication skills. Objectives: -Become an influential professional in global Drug Safety. -Combine life sciences and Information Technology. -Be committed to the people and society. José Alberto Ayala Ortiz (M.Sc. Pharm. and M.Sc. IT) is an expert in the field of Pharmacovigilance and Drug Safety. He has experience both from the Regulatory (Danish Medicines Agency), and from the Pharmaceutical Industry, where he has been responsible for Pharmacovigilance IT systems, databases and Electronic transmissions in Project Manager role. Besides his day-to-day Pharmacovigilance work as a consultant, he is an active trainer of the EVWeb and XEVMPD training courses since 2003, and collaborates together with the training team, the EMA and the DIA in the development of these training courses. He provides also EU QPPV services and local QPPV services in Spain for Pharmaceutical Companies. Specialties: Pharmacovigilance, Eudravigilance, ADR's management, electronic submissions, databases, signal generation, teaching experience. SPANISH: Experto en el campo de la Farmacovigilancia y la seguridad de los medicamentos. Tiene experiencia tanto por la parte Reguladora (Agencia Danesa del Medicamento), como de la industria farmacéutica, donde ha sido responsable de sistemas de IT relacionados con Farmacovigilancia, bases de datos y de las transmisiones electrónicas de reacciones adversas ICSRs/SUSARs. Además de su trabajo diario como consultor, es un entrenador de los cursos de formación de EVWeb y XEVMPD desde el año 2003, colabora con el equipo de entrenamiento de la EMA y la DIA en el desarrollo de estos cursos de formación. También proporciona servicio de EU QPPV y de Responsable local de FV en España para compañías farmacéuticas.
CEO, Pharmacovigilance Consultant
Since October 2009
-Pharmacovigilance services for the Pharmaceutical Industry. Work independently or in collaboration with other PV service providers / CRO's to provide: EU QPPV and Local QPPV services for Spain. Pharmacovigilance GVP Audits. Internal training for EVWeb and XEVMPD (Extended Eudravigilance Medicinal Product Dictionary) for pharmaceutical companies. Possibility of certified on-site training. Registration with Eudravigilance for Pharmaceutical companies. Introduction of information of medicinal products in the XEVMPD. Development of IDMP implementation consultancy services. Case management of suspected adverse reactions, including contact with reporters, MedDRA coding, Data Entry and Electronic reporting to health authorities. Literature searches for Pharmacovigilance. Implementation of the company's Pharmacovigilance system, including Standard Operating Procedures for Pharmacovigilance (SOPs/PNTs). Development and revision of Pharmacovigilance documents, including Periodic Safety Update Reports (PSURs), Risk management plans (RMPs) and Elaboration of the Pharmacovigilance System Master File.
EudraVigilance EVWeb and XEVMPD training courses
Since January 2004
Certified trainer of EudraVigilance XEVMPD (Extended EudraVigilance Medicinal Product dictionary) and EVWeb courses. Also have instructed Statistics for non-statisticians training course. This activity is ongoing since 2004 at several locations several times a year.
Pharmacovigilance officer and IT systems coordinator, Clinical Research and Development
June 2008 --- October 2009
Pharmacovigilance officer responsibility for development products against Cancer. SAEs, SUSARs, FSRs, ASRs, and input in IBs. Responsible for IT systems in Pharmacovigilance, PhV Database (Oracle AERS) and data management systems. Implementation of E2B exchange with Regulatory Agencies.
Rational Use of Medicines - Evidence Based Medicine, Regional Health Service
January 2008 --- June 2008
Location: Subdirección de Farmacia del Servicio Andaluz de Salud, Sevilla. Activity: Técnico en Uso Racional del Medicamento. The Servicio Andaluz de Salud is the Spanish regional equivalent to the NHS. -Activities related to the User of Evidence in Healthcare and Rational Use of Medicines (EBM), guidance on the use of new and existing medicines, treatments and procedures within the Health System. -Use of medicines, compassionate use and off-label use.
Pharmacovigilance officer and IT systems coordinator, National Competent Authority
January 2003 --- January 2007
Employer: Danish Medicines Agency, Ministry of the Interior and Health, Copenhagen. Position held: Pharmacovigilance officer and Database developer. -Responsible for the Adverse Reactions (ADRs) database administration and development. -Responsible and contact person for the electronic exchange of Individual Case Safety Reports (ICSRs) with the Pharmaceutical Industry and the EMA. -ADRs monitorisation and Data Management , Signal Generation. -Review of Periodic Safety Update Reports (PSURs) . -Be the representative person at the EMA’s Pharmacointelligence group (EVDWH). -Participate at the EMA’s JIG and TIG.
Outcomes Research Developer, Statistics and Outcomes Research, International Marketing
January 2000 --- January 2002
Employer: Novo Nordisk A/S, Denmark. Position held: Outcome Research Developer. -Statistical and epidemiological data analysis and reporting. -Application and Database development. -Internet and Intranet Development. -Advice and consultancy for IT projects.
Pharmacist at Community Pharmacy
January 1999 --- January 2000
-Dispensation and advice to patients on a daily basis. -Following up medication and provide pharmaceutical care to patients in collaboration with doctors and local clinics.
Course in Bioinformatics from Danmarks Tekniske Universitet in 2002
M.Sc. in Multidisciplinary IT Development from IT-Universitetet i København in 2002
Master of Science (MSc) in Pharmacy from Universidad de Granada in 2002
Specialist in Pharmacovigilance and drug safety from Fundacion empresa Universidad de Granada in 2002
Ldo. in Farmacia from Universidad de Granada in 2000
in International Stay from Danmarks Farmaceutiske Universitet in 1998
Training and Certification
Eudravigilance Certified Trainer Certification