PVpharm’s team returning to the Office: Lessons learned from remote working under COVID-19 restrictions

Post published:June 19, 2020

After a period of working from home because of the COVID-19 situation, we are happy to announce the re-incorporation of the PVpharm's team members to the Almería office (HQ). The team will be back in the office by Monday 22nd June, after a period of full remote working initiated in April following the instructions of the Spanish Health Authority and the WHO recommendations. PVpharm office during remote working period of COVID-19 During this remote working period, we collected a number of lessons learned from remote working. We would like to share with the community some points: Communication is key. During…

Pharmacovigilance Audits

Post published:April 8, 2020

EU Guidelines on Good Pharmacovigilance Practices (GVP Module IV), mandate that all Marketing Authorisation Holders (MAHs) perform audits of their Pharmacovigilance Systems. PVpharm provides a risk-based Pharmacovigilance Audit Service, which focuses on the areas of highest risk to an organisation’s pharmacovigilance system, taking into account applicable local regulatory requirements. Our approach is risk and process based, our objective is to improve your pharmacovigilance system in order to achieve excellence in quality. We can perform face-to-face or remote audits. Our audit team consist of a group of experts in pharmacovigilance with several years of experience. Please contact us for more information.

Remote working instructions at PVpharm

Post published:April 7, 2020

COVID-19:REMOTE WORKING INSTRUCTIONS AT PVPHARM Due to the Coronavirus outbreak, PVpharm decided that all employees should work from home. Only under special circumstances it would be allowed to come to the physical offices. We would like to share with the community our rules, our tips, so everyone can benefit of this learning. Please, stay safe at home, try to avoid going out. Protect yourself and the rest of the society. It is a matter of civil responsibility and public health. Follow the recommendations of the Government and the WHO. Remote working instructions at PVpharm 1 - Stay focussed and committed…

PHARMACOVIGILANCE TRAINING III Edition – Madrid 21-22 May 2020, Save the date! – UPDATE: postponed

Post published:March 20, 2020

PVpharm is organizing the III Edition of the PHARMACOVIGILANCE TRAINING, this year it will be held in Madrid. The training was originally scheduled for the 21-22 of May 2020, but it has been posponed due to COVID-19. We will publish the new dates very soon. The previous editions in 2018 and 2019 were really successful, so we continue with a similar format, giving the participants now the chance to send questions to the speakers in advance. This year again, we have the honour to count with very relevant and experienced Speakers that will share their PV knowledge with the participants: Doris…

COVID-19: Business continuity actions at PVpharm

Post published:March 14, 2020

Let's help everyone stop COVID-19! At PVpharm we adopted business continuity actions in order to save the health of the people working in PVpharm and provide continuation of our PV services to our dear customers. PVpharm is following the recommendations of the Spanish Health Authority, that is recommending to restrict movement of people due to the COVID-19 outbreak. PVpharm decided that all employees should work from home starting on Monday 16th March 2020. Only under special circumstances it would be allowed to come to the physical offices. No disruption in our services is expected from this situation. Our team will…

ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU: Hands-on Training Course using the EudraVigilance System Madrid (25th-27th March)

Post published:January 31, 2020

PVpharm is pleased to inform that our CEO, Jose Alberto Ayala Ortiz, will be participating as an instructor in a hands-on training course on the ISO/ICH E2B(R3) Individual Case Safety Reporting in the EU. The course will take place in Madrid from 25th to 27th of March and will provide the extensive information regarding EMA required knowledge evaluation, on how to report, view and download ICSRs using the EudraVigilance system and principles of EVDAS. This hands-on training course covers: In depth explanation and practical examples for creating, sending and accessing ICSRs in the ISO/ICH E2B(R3) format based on the EU ICSR…

Merry Christmas from PVpharm

Merry Christmas and a Prosperous New Year!

Post published:December 20, 2019

Merry Christmas from PVpharm Dear all, on behalf of the PVpharm Team I would like to wish you a Merry Christmas and a Prosperous New Year!

PVpharm opens an office in Madrid

Post published:December 16, 2019

We are happy to announce that PVpharm is opening an office in Madrid. For all our partners and collaborators we are welcoming you at our new location! PVpharm S.L. Núñez de Balboa, 35 Esquina Goya 5º Oficina A4 – 28001 Madrid PVpharm new office in Madrid PVpharm new office in Madrid

PVpharm participates in Nordic PV Day

Post published:October 26, 2019

On Thursday 24th October 2019 PVpharm participated at the Nordic Pharmacovigilance Day conference in Copenhagen, Denmark. Jose Alberto Ayala Ortiz, PVpharm CEO, was talking about Signal Detection using EVDAS. It was very nice to meet with former colleagues from the Danish Medicines Agency! Jose Alberto Ayala OrtizDoris Irene StenverVibeke Nielsen PVpharm also provides in-house trainings for pharmaceutical companies and CROs. For further information, please contact us.

PVpharm in PIPA conference 2019

Post published:October 26, 2019

On Wednesday 2nd - Thursday 3rd October 2019 PVpharm participated at the PIPA conference in Stratford Manor, near Birmingham. Jose Alberto Ayala Ortiz, PVpharm CEO, was talking about Signal Detection using EVDAS. José Alberto Ayala Ortiz presenting at the PIPA conference 2019 PVpharm also provides in-house trainings for pharmaceutical companies and CROs. For further information, please contact us.