Pharmacovigilance training – from an obligation to something fun!


Founded in Japan over 120 years ago, Santen is one of the world’s leading manufacturers of prescription ophthalmic pharmaceuticals. In Europe alone the company has over 700 employees working in around thirty different countries. Pharmacovigilance Manager, Deputy QPPV Piia Tirilä is responsible together with the rest of Santen’s pharmacovigilance team for overseeing pharmacovigilance issues in Europe. Piia’s job involves liaising with other pharmacovigilance experts at Santen’s local offices and providing pharmacovigilance training for employees.

Pharmaceutical companies are obligated by the EU legislation to provide pharmacovigilance training for all employees, both during orientation and on an annual basis. The aim is to ensure that each employee knows how to act when faced with pharmacovigilance, i.e. drug safety, issues.

“Naturally it is to the benefit of all parties – the company, authorities, consumers and medical staff – that we can collect as much information as possible about drug safety. Still, the obligation of studying the legal complexities of pharmacovigilance by means of PowerPoint presentations on an annual basis may seem burdensome to some employees, and the effectiveness of this training is sometimes questionable. So we decided to refresh our training methods,” Tirilä tells us.

Previously, organising training events required a lot of planning and coordination. “Our experts spent a lot of their working time repeating training sessions and travelling from one training venue to the next. Information about participants was gathered manually, and the chain of e-mails concerning arrangements was very long,” Tirilä explains.

In response to this situation, Santen has piloted a new Finnish innovation over the past year: the Medivillage learning environment where participants can find pharmacovigilance training material compiled by experts. When entering Medivillage each participant selects a character that corresponds to his or her role in the company and then begins moving through the learning area by answering questions.

“The advantage of this online learning environment is that employees can attend the course when it best suits them. Our employees have enjoyed this new way of learning things. It’s nice that pharmacovigilance training is now more appealing and that it strengthens our role in developing operations. In addition, our experts now have more time for their other obligations, since it is no longer necessary to arrange training events in different places. It’s also great that this new learning environment is suitable for use by many of our European units, since different language versions are also available,” Tirilä says.

Tirilä recommends Medivillage to others responsible for pharmacovigilance training for the following reasons:

  1. It’s easy to review training statistics. The system generates automatic reports about participants, eliminating the need for manual monitoring. The learning results are measured using a test built into the online environment.
  2. The training is no longer tied to place or time.
  3. The new tool inspires participants to learn. It makes pharmacovigilance more appealing and strengths our role in developing operations. This innovative training method enhances our reputation and promotes other forms of cooperation within the company.

In addition, she gives three tips for introducing Medivillage:

  1. Lists of participants must be kept up to date even when organising online training. HR systems play an important role in this regard.
  2. It’s important that the training method is effective, but other areas like reporting systems should also be effective to ensure that information related pharmacovigilance is shared throughout the organisation.
  3. In case of problems or questions related to the online training, contact channels should be clear and effective, and a contact person within the organisation should be designated. Any questions should be answered rapidly to avoid raising the threshold for using the new service.

Piia Tirilä, Santen
Pharmacovigilance Manager, Deputy QPPV