Pharmacovigilance services for the Pharmaceutical Industry.

PVpharm Pharmacovigilance Training II edition review

On 9th and 10th  May 2019, PVpharm provided a pharmacovigilance training in Madrid.

We had the honour to have as trainers:

  •  Mariano Madruga: a well known professional with more than 30 years dedicated experience in pharmacovigilance, being an official of the Ministry of health/AEMPS and developing the pharmacovigilance Network in Spain.
  • Calin Lungu: Dr. Lungu has worked more than 20 years in drug development, clinical research, pharmacovigilance and quality assurance. He has done more than 140 PV audits and trained more than 250 Eudravigilance and XEVMPD courses at the EMA
  • Albert García Rierola: The EU-Qualified person responsible for pharmacovigilance (QPPV) at Ferrer International. He has experience in different areas such as regulatory affairs and price and reimbursement,
  • Maite Vázquez: economist and lawyer, with training in Biotechnology and Pharma Law. She is the secretary of the Board of the Spanish Biotechnology Association (ASEBIO) and legal advisor in the Pharma and Health group of the Bar Association of Madrid (ICAM) and she has been advising companies in pharma and bio industry in regulatory, contracts, corporate and compliance matters.
  • José Alberto Ayala Ortiz: Pharmacist with specialty in IT who has been working more than 16 years in Pharmacovigilance and Drug Safety in multiple places including the Danish Agency and also as a trainer for EVWEB and XEVMPD trainings at the EMA and other locations.

During this course, we focused on different aspects and areas such as how a PV department is organized, the role of the QPPV and how this function is audited, personal data protection issues in PV, latest updates in the use of EVDAS for signal detection, ICSRs, PSURs, etc.

The training was held in Madrid, at the emblematic Hotel Emperador. The course was held in English, and there were participants coming from several locations across Europe. We could enjoy a fantastic atmosphere during the training and we would like to thank the participants for their valuable and professional contribution to the training.

Just like in the 1st edition, after the training, an anonymous questionnaire was administered to the participants in order to assess their satisfaction and to improve our performance on the coming editions. We would like to highlight 2 questions form the reviews:

Question 1. This course was…

As we can see, most of the participants, around 88%, describe the course as “excellent” or “very good”.

Question 2: How likely would you recommend this course to a friend or colleague (from 0 “not likely at all” to 10 “extremely likely”.

Participants assess the possibility of recommending this course to a friend or colleague as 9 (mean of the total answers).

The results were quite positive and we are very delighted and thankful to everyone for their inputs. We are looking forward to the 3rd edition!

PVpharm team.

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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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Pharmacovigilance training 1st edition review.

PVpharm organized a Pharmacovigilance training course on October 18th and 19th 2018.

We had the honour to have as trainers: Mariano Madurga (a well known professional with more than 30 years of dedicated experience in pharmacovigilance, being an official of the Ministry of health/AEMPS and developing the pharmacovigilance Network in Spain), Calin Lungu (Dr. Lungu has worked more than 20 years in drug development, clinical research, pharmacovigilance and quality assurance) and Jose Alberto Ayala Ortiz (pharmacist with specialty in IT who has been working more than 15 years in Pharmacovigilance and Drug safety in multiple places including the Danish Agency and also as trainer for EVWeb and XEVMPD trainings at the EMA and other locations). 

Our trainers focused on the latest regulatory changes involving Eudravigilance, Signal Detection and EVDAS, resolving doubts and showing real life examples on how the legislation should be applied in different situations.

The training was held at the heart of Madrid, the emblematic Hotel Emperador, where we could even enjoy the sunset on the terrace of the building after the 1st day of the course. This, and the rest of the breaks during the session, allowed the participants to network in a multicultural environment, as the participants came from many different locations.  

After the course, an anonymous poll was presented to each participant. We would like to highlight two questions from the anonymous reviews:

– The results from question 1 showed more than half of the participants rated the course as Excellent, and the rest considered the course was very good (Figure 1). 

 Figure 1. Question 1 results from the anonymous poll. 

– Question 2 results are the following:

How likely is it that you would recommend this course to a friend or colleague (from 0 “not likely at all” to 10 “Extremely likely”)Being 0 “not likely at all” and 10 “extremely likely”, participants assessed the possibility of recommending this course to a friend or colleague as 9,4 (mean of the total answers).

We are very pleased with the results from the course and we are already looking forward to prepare a second edition of this training. Thanks to all the participants!

Hope to see you all there to share more Pharmacovigilance knowledge! 

PVpharm Team.

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