Pharmacovigilance services for the Pharmaceutical Industry.
EVWEB Prague 15th-17th May
EVWeb training in Prague

EVWEB Prague 15th-17th May

José Alberto Ayala Ortiz, the CEO of PVpharm, will be participating as an instructor in the EVWEB training organized by the DIA association in Prague from the 15th till the 17th May.

This training, “The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B (R3) format”, will involve the functionalities of the new EVWEB application, practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B (R3) format.

For more information and registration, please visit DIA and EMA websites to find the full training programme.

PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

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PV Training II Edition is here!

After the success of the first edition of the I Pharmacovigilance Training, PVpharm is organizing its Pharmacovigilance Training II Edition on the 9th and 10th of May 2019 in Madrid.
The course will cover different trending topics in PV; focusing on Audits, Inspections, the QPPV role and Eudravigilance and Signal Detection. We will also cover the new GDPR from the perspective of Pharmacovigilance!
Our speakers include:

  • Mariano Madurga (Ex-Head of Co-Ordination Unit of the Spanish Pharmacovigilance System. Spanish Medicines and Healthcare Products Agency)
  • Calin Lungu (Lead EV and XEVMPD trainer, expert pharmacovigilance auditor, PV QA consultant, CEO of DDCS)
  • Maite Vazquez (Partner Life Sciences DA Lawyers)
  • Albert García Rierola (EU-QPPV / Head of Pharmacovigilance at Grupo Ferrer Internacional)
  • José Alberto Ayala Ortiz (PVpharm CEO, EU-QPPV, PV consultant)

For more information and to download our training brochure, please click here.
You can also contact us for any further information, we will be glad to help you.

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We are in the press!

Last Sunday, 10th March 2019, the news diary “La Razón” published an article about PVpharm; where our CEO, José Alberto Ayala Ortiz, introduces our company, explains what pharmacovigilance is and how does PVpharm deal with different regulations.

You can follow us on Linkedin and learn more about us clicking here.

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PVpharm provides Qualified Person for Pharmacovigilance Services (EU QPPV)

PVpharm provides EU Qualified Person for Pharmacovigilance (EU QPPV) and Deputy EU QPPV with large knowledge and experience of the industry. Besides, PVpharm has contact persons for pharmacovigilance in several EU countries

Any medicinal product cannot be authorized in the EU without a Qualified Person for Pharmacovigilance (EU QPPV). The EU QPPV is responsible for the establishment and maintenance of the MAH’s PV system, therefore must have adequate oversight and authority to affect the performance of the quality system and the PV activities, and to maintain and improve compliance with the legal requirements.
The EU QPPV has the following responsibilities regarding the medicinal products covered by the PV system:

  • Overview of medicinal product safety profiles and any visible safety concerns
  • Awareness of any conditions or obligations adopted as part of the MA and other loyalties
  • Awareness of risk minimisation measures

In the other hand, an EU QPPV must:

  • Act as a single point of contact for the European Medicines Agency (EMA) and EU Competent Authorities on a 24-hour basis, and the contact point of inspection
  • Ensure and verify that the pharmacovigilance system master file (PSMF) is constantly in place

The EU QPPV must have an adequate theoretical and practical knowledge for the performance of PV activities, reside in the European Economic Area (EEA) and be constantly at the disposal of the marketing authorization holder (MAH).
Why outsourcing your EU QPPV is important?
Outsourcing your Qualified Person for Pahrmacovigilance has many potential benefits:

  1. Lower costs and increased efficiency
  2. Reduces the number of resources to recruit, manage and train
  3. Converting fixed resource costs into variable
  4. Improved business model and flexibility
  5. Improving on-demand access to unique expertise, intellectual property, and multidisciplinary knowledge

The pharmaceutical industry expands in size and global reach, which makes it face new and complex challenges. Therefore, we are here to make it easier for you. Keep up with your product innovation, care about your technology advances and let all activities related to pharmacovigilance for us!
PVpharm can provide the EU QPPV expertise. Our EU QPPV is based in Spain, country of the EU.
PVpharm can also help you to improve on your PV system and ensure that it meets the requirements of the legislation by auditing your existing EU QPPV and PV system to identify any gap and advise on optimal arrangements.
PVpharm also provides Local Contact Persons of pharmacovigilance in several EU member states. The local contact person for pharmacovigilance are the primary contact persons for their local competent authority and work closely with the EU QPPV.
For more PVpharm services, please click here.
For further information, feel free to contact us.

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Meet us at Farmaforum!

PVpharm will participate as an exhibitor in the 6th edition of Farmaforum, one of the most important events of the Pharmaceutical Industry in Spain. The event will be held in Madrid at IFEMA (Pabellón 8-Feria de Madrid) on the 28th and 29th of March.

We are so excited and impatiently anticipating the day of the event. If you decide to visit us, we will be so happy to receive you at our stand, STAND C31, to provide you any kind of information regarding our company, services, careers, etc; or to just have a cup of coffee and share a nice talk.

To request an appointment, please contact us or visit us directly during the event. 
We will be waiting for you!

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EVWEB training in Amsterdam February 2019

The DIA is organizing an EVWEB training in which José Alberto Ayala Ortiz will participate as a trainer. The course will be taking place in Amsterdam, exactly at the BCN Amsterdam Arena from the 11th to the 13th February 2019.​SMLXL

 The hands-on training “The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B (R3) format” covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B (R·) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.
For more information and registration, please find the link to the EVWEB course and the complete courses program available on EMA website.PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

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Open positions: Senior Pharmacovigilance officer

PVpharm is searching for a Senior Pharmacovigilance officer to provide support for clients and work closely within PVpharm’s team in our headquarters in Almería.

This position requires documented experience in Pharmacovigilance, organizational and team management skills and willingness to drive the team and the organization to the highest level. 

Job description
As a senior pharmacovigilance officer you will be involved with different projects, you will assume multi-project responsibility and will provide your expertise within different areas of Pharmacovigilance.

Your activities will be mainly:

  • Coordinate several PV projects
  • Assume responsibility for complex PV projects
  • Create business procedures
  • Master European and local Pharmacovigilance legislation requirements and liaise with regulatory authorities 
  • Set up and maintain PV systems in line with company SOPs
  • Receipt and process adverse events
  • Provide support in the creation of periodic reports (PSURs)
  • Support audit, inspections and implementation of CAPAs

Requirements:

  • At least 4 years of documented PV experience in the pharmaceutical industry/CRO
  • Life sciences education
  • Management skills 
  • Good communication skills 
  • Excellent command of Spanish and English
  • Team player, proactive and quality minded
  • Ability to work independently and assume responsibilities

What would you achieve:

  • Excellent opportunity to step-up in your career in Pharmacovigilance
  • Excellent opportunity to work for a company with focus on personal and professional development
  • Excellent opportunity to work for projects with important international and national pharmaceutical companies
  • Perfect timing to join a young and fast growing international pharmacovigilance service provider with multiple career development opportunities 

Please send your CV and motivation letter to: info@pvpharm.com

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EVWEB training in Amsterdam December 2018

Amsterdam is the next place where the DIA is organizing an EVWeb training. The course will take place at the BCN Amsterdam Arena on December 10th to 12th. José Alberto Ayala Ortiz is participating as trainer for this course.

The EVWeb hands-on training  “The new EudraVigilance system and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format: hands-on training course, Amsterdam, The Netherlands” covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI “Management and reporting of adverse reactions to medicinal products” and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance Access Policy.

Please find the link to the EVWeb course and the complete courses program available from the EMA website.

PVpharm is also organizing in-house trainings in pharmacovigilance for pharmaceutical companies and CROs, please contact us for further information.

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EVWEB and XEVMPD training in London November 2018

The DIA is organizing an EVWeb and XEVMPD training course at EMA in London in June, respectively on the dates 12-14 and 15-16. José Alberto Ayala Ortiz is participating as trainer for these courses.

The EVWeb  hands-on training  “The NEW EudraVigilance System and the electronic reporting of ICSRs in the ISO/ICH E2B(R3) format” covers the functionalities of the new EudraVigilance web application (EVWEB). It includes practical examples for creating, sending and accessing ICSRs in the new ISO/ICH E2B(R3) format. It covers reporting principles in accordance with the guideline on good pharmacovigilance practices (GVP) Module VI ‘Management and reporting of adverse reactions to medicinal products’ and explanations on how to comply with the EudraVigilance business rules and the EudraVigilance access policy.

The “eXtended EudraVigilance Medicinal Product Dictionary” training focuses on explaining the guidance and specifically the mandatory data elements necessary for the electronic submission of information on medicinal products, applying the format of the eXtended EudraVigilance Product Report Message (XEVPRM) and the use of the XEVMPD data entry tool (EVWEB). It includes exercises in the XEVPRM data entry tool (EVWEB) for the electronic submission and maintenance of different types of medicinal products.

The course also includes instructions for sponsors of clinical trials on how to provide information on Investigational Medicinal Products (IMPs) in the medicinal product dictionary before completing the clinical trials application form.

Please find the link to the EVWeb course from the EMA website and the complete courses program available from DIA.

PVpharm is organizing in-house trainings for pharmaceutical companies and CROs, please contact us for further information.

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PVpharm to participate at EUPV Congress in Milano

PEC – Pharma Education Center S.r.l. warmly invites PV professionals from all over the world to the “European Pharmacovigilance Congress – 2nd Edition” which will be held on November 29-30, 2018in Milan, Italy. The core of the 2nd European Pharmacovigilance congress are the significant changes and challenges due to the EUDRAVIGILANCE implementation.

PVpharm will be participating in the Congress.  José Ortiz, our experienced trainer, will present a session with focus on Pharmacovigilance Quality System and impacts from the new Eudravigilance requirements.

Others key speakers will give out updates about latest Inspection Trends in Pharmacovigilance, how is changing the Signal Detection process, which is the impact of new requirements on the PV process as well as deepen PV quality system and a lot more! In-depth analysis will be given on Patients Support Programmes (PSP) and engagement for the set up of appropriate risk management and risk minimization measures.

This 2 day Congress will offer in total 12 sessions of oral talks and keynotes presentations, including round-tables, networking lunch sittings, exhibit area to showcase new and emerging technologies.


WHY TO ATTEND

The European Pharmacovigilance Congress represents a great opportunity for professionals and stakeholders to meet targeted audience and fully interact with participants from the Pharma, Clinical and Regulatory community.
This European event is a unique opportunity for exhibitors and sponsors to engage with global industry partners!

For more information take a look at the Congress website: 

https://www.eupharmacovigilance.com/

REMEMBER!
PVpharm is always keeping up with the last changes in pharmacovigilance and organize trainings adapted to every necessity. Take a look to our training page for more information.

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