Pharmacovigilance – Professional services for Drug Safety
Our Pharmacovigilance services include:
- Evaluation of the current PV status
- Conducting literature research
- Periodic Safety Update Reports (PSURs)
- Development Safety Update Reports (DSURs)
- EU-conform electronic reporting (XEVPRM, ICSR)
- Implementation of PV systems
- Compilation of Risk Management Plans (RMPs)
- Training, audit and more
Mediconomics offers bespoke pharmacovigilance (PV) services for the pharmaceutical industry. Our team of experts supports you in both clinical trials and with approved and marketed products. With our extensive experience, we ensure the highest quality and full compliance with all regulatory requirements.
Our Pharmacovigilance flyer is available for download.
Pharmacovigilance for Approved and Marketed Products
Continuous Safety Monitoring
The safety of medicinal products is our top priority. We implement robust systems for the comprehensive collection and assessment of adverse drug reactions (ADRs) in accordance with Good Vigilance Practice (GVP) requirements. Our team employs advanced methods for the early identification and evaluation of potential safety signals to proactively address possible risks. Our services include:
- Implementation and maintenance of pharmacovigilance databases
- Conducting regular signal detection analyses
- Preparation of Individual Case Safety Reports (ICSRs) and follow-up reports
- Development and implementation of risk minimisation measures
Regulatory Safety Reports
We support you in the preparation and submission of Periodic Safety Update Reports (PSURs) in accordance with EMA and national authority requirements. Additionally, we develop, update, and implement Risk Management Plans (RMPs) for proactive risk minimisation. Our goal is to continuously monitor and improve the safety of your products. Our specific services include:
- Preparation and submission of PSURs and RMPs
- Conducting benefit-risk assessments
- Updating product information (SmPC, PIL)
- Assistance in the preparation of Direct Healthcare Professional Communications (DHPCs)
Regulatory Reporting Obligations
Our experts ensure the timely submission of Individual Case Safety Reports (ICSRs) to relevant authorities via EudraVigilance. We ensure that all regulatory requirements are met and that you are optimally prepared for inspections. We offer:
- Timely reporting of ICSRs to authorities and EudraVigilance
- Preparation and support for inspections
- Creation and maintenance of Standard Operating Procedures (SOPs)
Risk Communication and Management
Effective communication is crucial for drug safety. We develop and implement strategies for communicating safety information to healthcare professionals and patients. Additionally, we implement and monitor risk minimisation measures, including the creation of training materials for healthcare professionals and patients. Our services include:
- Development of risk communication strategies
- Implementation and monitoring of risk minimisation measures
- Conducting effectiveness studies for risk minimisation measures
Quality Management in Pharmacovigilance
Our robust pharmacovigilance quality management system, in accordance with GVP Module I, ensures the highest standards. We regularly conduct internal audits and manage Corrective and Preventive Actions (CAPAs) for continuous system improvement. Our services include:
- Implementation and maintenance of quality management systems
- Conducting internal audits and gap analyses
- Management of CAPAs and improvement measures
PSMF Creation and Maintenance
The Pharmacovigilance System Master File (PSMF) is a central document in pharmacovigilance. We continuously create and update your PSMF to provide a detailed description of your PV system and ensure preparedness for inspections. We offer:
- Creation and continuous updating of the PSMF
- Regular review and adjustment to regulatory changes
- Support in the integration of new products into the PSMF
Pharmacovigilance for Clinical Trials
Comprehensive Safety Monitoring
For clinical trials, we implement robust systems for continuous monitoring of adverse events throughout the entire study duration. We develop and apply study specific risk management plans to proactively identify and minimise potential safety risks. Our services include:
- Development and implementation of safety monitoring plans
- Creation and maintenance of safety databases for clinical trials
- Conducting risk assessments and management
- Support in the preparation of study protocols and informed consent forms
Efficient SAE and SUSAR Management
Our team ensures timely capture, assessment, and documentation of Serious Adverse Events (SAEs) in accordance with GCP regulations. We ensure prompt reporting of Suspected Unexpected Serious Adverse Reactions (SUSARs) to authorities and ethics committees within prescribed deadlines. We offer:
- 24/7 availability for SAE reporting
- Medical evaluation and follow-up of SAEs
- Timely SUSAR reporting to authorities and ethics committees
- Preparation of safety reports for investigators and sponsors
Preparation of Regulatory Safety Reports
We prepare comprehensive Development Safety Update Reports (DSURs) in accordance with ICH-E2F guidelines and conduct continuous benefit-risk evaluations to ensure the safety of study participants. Our services include:
- Preparation and submission of DSURs
- Conducting benefit-risk analyses for investigational medicinal products
- Support in the preparation of annual reports for ethics committees
- Updating investigator’s brochures based on safety data
Contact us for individualised consultation on how we can optimally support your specific pharmacovigilance requirements. Benefit from our expertise and focus on your core competencies in drug development and marketing.
FAQ – frequently asked questions
What is Pharmacovigilance in practical terms?
Pharmacovigilance includes all activities related to monitoring the safety of medicinal products with the aim of detecting adverse effects and subsequently taking measures to minimise risks.
The most essential tasks in practice are the continuous monitoring of the risks in relation to the benefits of a medicinal product after marketing authorisation and the evaluation of incoming suspected cases of adverse reactions after marketing authorisation and after market launch.
The MDR also formalises the concept of vigilance in the field of medical devices, which deals with product safety from the time of marketing.
Who needs support in the area of Pharmacovigilance?
A sponsor or marketing authorisation holder may engage a contract research organisation (CRO) to perform pharmacovigilance tasks for the period during which a clinical trial is being conducted to test a medicinal product or also for the period after marketing authorisation and market launch.
Who provides professional support in the area of Pharmacovigilance?
Contract research organisations (CROs) – such as Mediconomics – are service providers in the medical field and offer professional support in the area of Pharmacovigilance (PV). For instance, CRO experts can oversee the development and maintenance of PV master data or the risk management plan, prepare safety reports, manage the legally compliant processing and submission of safety reports on individual cases in the form of ICSRs or conduct audits and training. In addition, companies can provide specialised persons who are required to have specific qualifications, such as the QPPV.
Why should I outsource pharmacovigilance activities?
Outsourcing pharmacovigilance (PV) activities offers numerous advantages, including cost efficiency, access to specialised expertise and technologies, and the ability to focus on core competencies. By collaborating with an experienced service provider such as Mediconomics, you can ensure that all regulatory requirements are met while simultaneously optimising internal resources.
How do you ensure data security and confidentiality when handling sensitive patient data?
Data security and confidentiality are of paramount importance to our organisation. We implement state-of-the-art security measures, including encryption, access controls and regular security audits. Our systems and processes are fully compliant with the General Data Protection Regulation (GDPR), and we conduct regular data security training for our staff.
How do you integrate your services into our existing processes and systems?
We collaborate closely with you to seamlessly integrate our services into your existing processes and systems. This encompasses tailoring our systems to your requirements, training your personnel and maintaining continuous communication to ensure all activities proceed smoothly and efficiently.
How do you handle international differences in reporting deadlines and requirements?
Our team is thoroughly familiar with the international variations in reporting deadlines and requirements. We have established processes to ensure that all reports are submitted in a timely manner and in accordance with the respective national regulations. Our international reach and local expertise enable us to efficiently meet the requirements across various countries.
Drug safety through continuous monitoring
The word Pharmacovigilance or drug safety is composed of the Greek word pharmakon, meaning “remedy” or “poison”, and the Latin vigilantia “care, vigilance”.
In practice, it entails continuous and systematic monitoring of the safety of medicinal products for humans and animals, thereby allowing risks to be minimised. This is achieved by assessing and understanding adverse effects and taking appropriate action.
Compliance with legal requirements
Following the clinical development of a medicinal product, continued observation and documentation of adverse events are indispensable and legally required, even after marketing authorisation has been granted. Indeed, due to the limited number of subjects in clinical trials, rare side effects and interactions can often be detected only after market launch. Therefore, it is critical that all side effects associated with the product are carefully documented and submitted to the relevant authorities.
Patient protection is paramount
In the event of a suspected side effect, immediate reporting is obligatory, even if a causal relationship between the medicinal product and the effect cannot be established beyond doubt. Unexpected adverse reactions are of particular interest for the overall evaluation of a medicinal product. Through continuous medical-scientific development, new safety-relevant findings can be determined even years after a marketing authorisation is obtained. This may mean that the authorisation status of a long-established medicinal product must be adapted to current scientific knowledge, and, if necessary, information must be provided on risks and their mitigation.
A corresponding vigilance system exists for medical devices, the establishment of which is prescribed by European medical device legislation.
We take over your obligations for drug safety as a marketing authorisation holder.
Pharmacovigilance (PV) legislation was formalised and implemented by the EU in 2012 in order to regulate the detection, management and prevention of adverse reactions to medicines in patients. In line with these changes and in order to fulfil and implement the obligations of Pharmacovigilance, organisations authorised to produce a medicinal product for human use now require the services of a Qualified Person responsible for Pharmacovigilance (QPPV). Mediconomics have the expertise and approval of the European Medicines Agency (EMA) to provide your organisation with tailor-made Pharmacovigilance solutions, saving you valuable time and expense.
| EU-QPPV | Graduated Plan Officer (AMG) | |
|---|---|---|
| Residence | EU/EEA Member State | EU Member State |
| Responsibilities | Medical deficiencies | Medical and pharmaceutical deficiencies |
| Liability | MAH | Personal liability |
| Penalties | No | Yes |
| Backup | Yes, backup procedure and backup person must be available | Desirable |
| Contact/Reporting | Acts as central point of contact for competent authorities of EU member states and for inspections. 24/7 coverage necessary | Obligation to report risks of medicinal products and to report further information at the request of the competent authority |
| PV-System | Establishment and maintenance | Establishing and maintaining as well as collecting and evaluating drug risks and coordination of necessary measures |
| PSMF | Safeguard that the information in the PSMF is an accurate and up-to-date reflection of the PV system. | No |
