The role of the local pharmacovigilance contact is a key part of ensuring the safety of medicinal products. Medimo provides expert support to its clients as a local pharmacovigilance contact, assisting companies in maintaining medicine safety at all levels.
Close monitoring of local regulations
“Our task is to monitor local legislation and ensure that our clients are informed of any changes that may affect their operations,” says Meri Tanner, pharmacovigilance and regulatory affairs specialist at Medimo.
Medimo ensures that all regulatory changes are handled professionally and on time, so that clients are not left alone to deal with them.
The role of the local pharmacovigilance contact – tasks vary based on client needs
Medimo’s role as a local pharmacovigilance contact covers a wide range of responsibilities, defined according to each client’s specific requirements. One of the core tasks is the processing and reporting of adverse event cases.
“Adverse event reports are one of our key responsibilities,” says Hanna Hartikka, regulatory affairs and pharmacovigilance specialist at Medimo. Medimo also handles other pharmacovigilance duties, such as local literature monitoring and risk management activities.
In Finland, literature monitoring follows EMA’s Good Pharmacovigilance Practices (GVP) Module VI and Veterinary good pharmacovigilance practices (vGVP) Module Collection and recording of suspected adverse events for veterinary medicinal products. The Finnish authority does not specify an exact list of human medical journals to be monitored. Instead, each marketing authorisation holder decides which sources are relevant based on their product portfolio. In practice, companies are expected to monitor at least Suomen Lääkärilehti and Duodecim. This process is an essential part of local pharmacovigilance to ensure that adverse events and other safety information are tracked and reported in line with national requirements.
“Core responsibilities may include many types of tasks, but we always tailor our services to meet the client’s individual needs and expectations,” adds Meri Tanner.
Navigating regulatory differences in the Nordic countries
Medimo’s role is not limited to Finland. The company also provides pharmacovigilance expertise in other Nordic countries. While EU legislation is largely harmonised, there can be small but important differences between countries. For example, language requirements may vary. There may also be differences in reporting practices, such as deadlines and data collection procedures.
Pharmacovigilance tasks are defined under EU legislation and GVP/vGVP guidelines, but local adaptations still exist. Medimo ensures that clients remain compliant with these country-specific requirements and stay informed about any practical changes.
“In a regulatory environment like this, even small changes can have a significant impact on operations and reporting,” Meri adds.
Combining expertise with agility
One of Medimo’s key strengths is its expertise and ability to provide tailored solutions based on each client’s needs.
“We have extensive experience in both the pharmaceutical industry and regulatory authorities, which makes us a well-rounded and knowledgeable partner,” says Hanna Hartikka.
Medimo stands out not only for its expertise but also for its agility.
“As a small company, we can respond quickly to client needs. We are highly flexible, and for our clients, that means fast and expert service,” Hanna adds.
Medimo’s skilled team includes professionals from various fields. Meri Tanner highlights that this diversity is one of the company’s greatest strengths.
“We bring together a wide range of specialised expertise, which ensures the best possible service for our clients,” Meri says.
Data protection and safety
Data protection is one of the most important aspects of pharmacovigilance, especially when handling adverse event reports.
“We comply with the EU General Data Protection Regulation and ensure that all safety data is processed correctly and in accordance with applicable regulations,” says Meri Tanner.
Medimo also closely monitors all reporting requirements and deadlines related to safety data and adverse events.
“We make sure that all reports are completed accurately and submitted on time,” Meri adds.
Regulatory changes and future challenges
Pharmacovigilance is continuously evolving, and the role of data analysis is expected to grow significantly in the future. The adoption of technologies such as artificial intelligence and analytics tools enables a more proactive approach to safety monitoring.
“Regulatory requirements are constantly changing, and in the future, the role of the local pharmacovigilance contact will shift increasingly from reactive reporting to proactive safety management,” says Meri Tanner.
Medimo’s role as a local pharmacovigilance contact is essential in ensuring the safety of human and veterinary medicinal products and meeting regulatory requirements. As a local pharmacovigilance contact, Medimo provides expert support in managing regulatory changes and ensuring compliance.
