Pharmacovigilance services for the Pharmaceutical Industry.

About us

We are a team of consultants that works independently or collaborate with organizations and consultancies to deliver professional solutions to complex, specialized needs.

We are in continuous development and are open for new challenges and collaborations.

  • We stay focused
  • We have an innovative and can-do attitude
  • We solve the problem with excellence

Management board

José Ortiz

CEO – Pharmacovigilance Consultant

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 IT systems and Electronic transmissions. 

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 local QPPV services for Pharmaceutical Companies.

Jan Kolouch

Head of Pharmacovigilance and Clinical Safety

Jan is an experienced PV professional with a pharmacy background. He has been working at various PV positions for several years and currently works as Head of Pharmacovigilance and Clinical Safety department at PVpharm. The main focus of activities was on ICSR Management, EudraVigilance and XEVMPD set-up and maintenance, EU QPPV and Deputy EU QPPV activities, signal management, PSMF development/maintenance, medical writing (PSURs, RMPs, DSURs), Safety Database administration, audits/inspections and CAPA management. 

Apart from all above, Jan is also a trainer for various pharmacovigilance courses and collaborates with the DIA in the development of these training courses.

Vojtech Kvita

Head of Quality Assurance

Vojtech is a qualified expert in pharmacovigilance with 6 years of experience throughout which he worked on different positions across all PV areas, he has been EU-QPPV, Local Contact Person for Pharmacovigilance andAssociate Director/ Head of Safety Reporting Unit among other positions. The wide exposure to global clients (both sponsors and MAHs) has helped him to gain an extensive overview of critical PV processes and systems.

Vojtech is also involved in collaboration with DIA in creation and delivery of specialized pharmacovigilance courses and trainings. Vojtech is providing his support and expertise to the PVpharm team and is involved in several key projects. He is Head of QA at PVpharm.

Elena Marín Cassinello

Head of Finance and Human Resources

Elena has experience in the field of pharmacovigilance, statistics and research. With an expert degree in Pharmacovigilance by the University of Alcalá de Henares, she is very active in pharmacovigilance operations, she has been providing the deputy QPPV and Local Safety Officer function for several projects at PVpharm. She has been also involved in pharmacovigilance intelligence projects, liaising with information from authorities around the world. She is also interacting with clients providing SOP support, regulatory information and other client related day to day pharmacovigilance activities as well as literature surveillance and submission of ICSRs, SUSARs and XEVMPD messages to Authorities. 

Elena is a key person at PVpharm, she is at the moment Head of Finance and Human Resources and is involved in many other activities providing her experience and expertise.

Social Responsibility

PVpharm is committed with people and society. In PVpharm we believe that companies have a responsibility over for the community, and we try to do our best to support at several levels and as much as we can. Together we can make a difference.

Training programs and internships 

At PVpharm we believe that young graduates should have an opportunity. This opportunity will be very valuable in their future career. We are collaborating with several educational institutions as well as with the Erasmus+ program, please see our Recent Graduates program at our CAREERS page. 

Scientific, Business and Ecomonic Empowerment

At PVpharm we are committed with Science, business and Economic Empowerment. We are proud to be members of ISoP (International Society of Pharmacovigilance), AEFI (Spanish Association of Industry Pharmacists), SEFAC (Spanish Society of Comunity Pharmacists), ASEMPAL (Association of Business Entrepreneurs of Almería) and FAEEM (Business Excellence Foundation of Almería).

Save the children

At PVpharm we are commitment to the most vulnerable children, this is why we are supporting Save the Children and their special program of children support. Please read more about this program here

Culture

At PVpharm we love culture. We are participating at several cultural local initiatives, as we believe we can make a difference. We are supporting the “Indalian foundation for music and arts“.