Pharmacovigilance and Medical Information
Case Study

Discover how we supported our client to establish a pharmacovigilance and medical information system fully compliant with EU requirements 



Pharmacovigilance and Medical Information Case Study


Since 2017, we have been providing post-marketing pharmacovigilance services for MendeliKABS, a North American pharmaceutical company developing and commercialising rare disease therapies. This has involved set up of a comprehensive pharmacovigilance system compliant with the requirements for company’s product authorisation in the European Union (EU) and beyond. We have successfully acted as an extension to the client’s internal team, offering specialist expertise and ensuring our client remains compliant with its pharmacovigilance requirements.

The Challenge

Upon submission of a marketing authorisation application, it is imperative that a comprehensive post-authorisation pharmacovigilance system is put in place to ensure continuous safety surveillance once the product is licensed and marketed. As MendeliKABS is based in North America, they required a pharmacovigilance provider who could offer EU expertise, along with guidance and support in navigating and fulfilling EU requirements.

Additionally, the fact that this project involves a rare disease product developed under an orphan drug indication and has a relatively small patient population, including paediatric populations, means that ongoing monitoring of the safety profile and adherence to the EU Population Specific Considerations guidance is highly important.

Our Solution

Outsourcing the post-marketing pharmacovigilance activities to a service provider with a proven track record in the setup and management of post-authorisation pharmacovigilance systems, such as ourselves, can provide a cost-effective solution to meeting the complex regulatory requirements for all medicinal products globally, as well as specific requirements for authorisation in the EU including access to the required expertise of an EU-QPPV.

As per our capability, we were able to offer a tailored, flexible solution to the needs of this particular client, including:

  • EU Qualified Person Responsible for Pharmacovigilance (QPPV): provision of an experienced EU QPPV to support and oversee the pharmacovigilance system
  • Local QPPV network: provision of a local representative in specific member states within the EU, and local literature monitoring
  • Global literature screening: weekly monitoring of global literature to identify any emerging safety information
  • Safety database: set-up and hosting the Oracle Argus safety database which is the main repository for collected safety information
  • Individual Case Safety Report (ICSR) processing: collection and processing of ICSRs from all sources, as well as expedited reporting
  • Aggregate report production: authoring, review and submission of the periodic report (PSUR/PBRER), as a comprehensive safety profile overview for the product
  • Eudravigilance services: provision of the Responsible Person and Trusted Deputy to manage all aspects of Eudravigilance registration and set-up
  • Pharmacovigilance System Master File (PSMF) management: authoring, review and ongoing maintenance of the PSMF
  • Risk Management Plan (RMP) input: provision of review and input into content for the RMP
  • Regulatory intelligence: active monitoring of regulatory information from local, regional and global authorities for pharmacovigilance and product related updates

Additionally, we have worked closely with our partner ESMS Global for their provision of Medical Information services, including putting in place a tripartite Safety Data Exchange Agreement (SDEA) to ensure seamless exchange and reconciliation of relevant safety information arising from medical enquiries and product quality complaints.


We pride ourselves on our ability to offer flexible, tailored services to our clients, and this has been one of the key factors in ensuring the ongoing success of this project. Its success also lies in the effective partnership between the client, ESMS and ourselves, whose service offerings have perfectly complemented each other and enabled a successful working collaboration between the three parties.


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