PV-AS-A-SERVICE
Pharmacovigilance is crucial in ensuring patient safety. We accompany you from identifying the necessary steps to reduce risks up to an efficient implementation.
With any pharmaceutical product, you have to ensure the safety of the patient. A crucial factor in identifying the potential risks of a medicine is the detection, monitoring, and prevention of adverse effects – which is where Pharmacovigilance comes in.
Whether you need someone to take care of your PV processes as a whole or to tackle a particular challenge, our qualified team supports you along the way, from detecting the necessary steps to an efficient, high-quality implementation.
To provide security and safety to both you and patients alike, our PV services include:
Pharmacovigilance Guidelines
Pharmacovigilance must follow an array of specific guidleines and regulations.
With our experience and knowledge of the EEA as a whole, a variety of states within it, and further countries worldwide, we guide you through the specific PV needs of those markets, always assessing the situation from the right angle.
Medical Writing
From clinical development to market authorization application (MAA) to post-marketing – we take care of preparing PV documents through the entire lifecycle of your product, in compliance with all required quality standards.
PV System Master File (PSMF)
As not only a requirement for submitting your product’s application for Marketing Authorization within the EEA but also the basis of your PV system, the PSMF takes on a particularly important role in Pharmacovigilance.
We therefore approach this subject with special care, making sure to include all necessary information, follow the strict structure determined by guidelines, and keep it up to date at all times.
SDEA Partner Management
Especially when you have a lot of partners all around the world or multiple different Safety Data Exchange Agreements, it can be difficult to handle them all without losing track.
Our job is to ensure that all necessary agreements are in place and to take care of their ongoing maintenance.Medical Literature Monitoring
Since medical literature is an important source to identify suspected adverse reactions, marketing authorization holders withing the EEA are usually responsible to monitor it closely and to report any cases.
With our experience, we take care of the monitoring and ensure a consistent, high-quality reporting.
Article 57 Database
The marketing authorization holder has the legal responsibility of keeping the information about their products up to date in the Article 57 database, a comprehensive repository of structured information on all medicines authorized in the EEA.
Our expertise ensures the registered data is correct, from the submission to the maintenance of your products’ information in accordance with European Union legislation.
Signal Management
As marketing authorization holder, it’s your joint responsibility with the regulatory authorities of the member states and the EMA to manage safety signals.
We support you in detecting signals from multiple sources as well as in their evaluation and management.
ICSR Management
Processing Individual Case Safety Reports (ICSR) is an essential part of any PV system.
To make sure you don’t have to worry about Case Management, our Pharmacovigilance team takes care of everything – from an efficient data collection, MedDRA coding and entry, to quality and medical reviews, and finally to the regulatory submission to all relevant parties.
SUSAR Management
Adverse events also have to be monitored and managed accordingly during the research phase of a medicinal product.
We take care of Suspected Unexpected Serious Adverse Reaction (SUSAR) in particular, keeping the relevant ICH guidelines as well as the narrow reporting periods in mind.
QMS and SOP Writing
One of the key factors in providing a Pharmacovigilance that works in all areas is a refined Quality Management System for PV.
We create and implement this necessary framework from the outset, including a complete library of necessary SOP documents, that ensures all related activities are performed in compliance with current laws and regulations – and at the high level of quality you want to deliver to the patient in the end.
Key PV Positions
Local responsible personnel for PV needed?
We cover not only European positions, such as QPPV and Deputy QPPV but also local positions required in different countries for PV, for example the Graduated Plan Officer/Stufenplanbeauftragte in Germany.
PV Consultancy
If you need advice on how to improve your PV processes in general or are facing any other topics in this area, our team is ready to guide you through the complex world of Pharmacovigilance.
We can help you regarding PV regulations and tasks within the EEA and in other countries worlwide.
