Pharmacovigilance
Med Communications’ team of highly skilled pharmacovigilance professionals bring practical experience and diverse perspectives to the table, having worked with a variety of product portfolios including pharma, vaccine, cosmetics, medical devices, and combination products. Our PV specialists have medical, pharmaceutical, and scientific backgrounds, and many held positions in sponsor and MAH organizations before joining Med Communications.
Our pharmacovigilance team features independent thinkers who help create tailored solutions for our clients and adapt to evolving needs of the industry. Backed by the latest applicable technology, our staff is able to provide flexible and compliant solutions for our clients, acting as true partners for your in-house teams.
Med Communications works closely with clients to cover all aspects of the pharmacovigilance process, including individual case safety reports, periodic reports, signal detection activities, and reports to regulatory authorities. We have established pharmacovigilance systems in the US and many countries worldwide, including in the EMEA and APAC regions.
We continuously keep track of technological trends and the regulators’ views on them, as we are exploring possibilities to leverage technology in order to optimize our internal PV processes and increase efficiency while decreasing costs.
Whether you are looking for a flexible service provider that offers a complete pharmacovigilance program or just want to outsource some parts of your PV activities, we are the right partner for you.
Full Suite of Pharmacovigilance Services:
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Case Processing
At Med Communications, we provide full support for pharmacovigilance (PV) projects—from all phases of clinical trials, over spontaneous and solicited post-marketing individual case safety reports (ICSR), to patient support programs, pregnancy registries, and scientific and medical literature reports. We offer our clients complete end-to-end workflow management for their PV activities, including collection, processing, medical evaluation, and single case reporting of adverse events.
Our PV team includes professionals from various medical, pharmaceutical, and academic backgrounds who together offer a broad range of experience and knowledge in the different case processing areas. We assess the validity and seriousness of incoming cases and ensure the timelines for submission to regulatory authorities are met. At the core of case processing, we determine causality as well as listedness according to the reference safety information of the product. In addition to routine case reports of adverse events, we also process special situations, such as pregnancy, overdose, abuse, misuse, lack of effect, and medication errors.
We handle compliant submissions of single cases following the E2B R2 and R3 standards via industry standard gateways. We use state-of-the-art database software, such as Argus and SafetyEasy, to process and report cases to regulatory authorities. Our expertise includes working within the regulatory environments of the United States, with the Food and Drug Administration (FDA), and Europe, with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA), as well as other regulatory agencies worldwide. With a functional PV system in place, our depth of experience gives us the unique opportunity not only to offer our clients support in the markets within which their products are already available, but also to assist during expansion into new markets.
In addition to processing and submitting cases in a high-quality and compliant manner, we conduct reconciliation with teams in other non-PV functions, such as medical information, study teams, quality assurance teams, and other business partners.
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Aggregate Reports
Aggregate reports provide periodic review of safety data in a global and cumulative way instead of looking at individual cases. While the concept is simple, the process can become complex to manage. To understand the benefit-risk profile of a product, the process requires the collection and assessment of safety data, as well as handling the necessary aggregate reports across a product’s lifecycle in various markets.
The Med Communications Pharmacovigilance (PV) team provides complete end-to-end management of all aggregate report types including, but not limited to, the Periodic Adverse Drug Experience Report (PADER or PAER); the Periodic Benefit Risk Evaluation Report (PBRER); the legacy Periodic Safety Update Report (PSUR), which is still used in some markets; and Investigational New Drug (IND) Annual Reports, especially where there is no Development Safety Update Report (DSUR) waiver available. Our PV services include periodic submission of individual case safety reports (ICSRs) to the appropriate regulatory authorities in support of the aggregate reports. Our PV team can also handle ad hoc report requests, such as Suspected Unexpected Serious Adverse Reaction (SUSAR)/Serious Adverse Event (SAE)/Adverse Event (AE) line listings, AE summary tabulations, and CIOMS II line listings, for clients and regulatory authorities.
Aggregate reports project management assists clients with templates, data retrieval/requests, the review process, and timelines to facilitate the contribution of the different stakeholders involved in the process and to assure compliance with submission deadlines. To analyze the data and draft the content of the required reports, our experienced PV professionals query the safety database to retrieve the necessary data and listings to be analyzed and review the additional information provided by the client. As a standard to the aggregate reports process, the PV team employs internal quality and medical reviews before submitting the reports to the client for their review and approval.
Our PV team will use their expertise and all available tools to assist clients with forecasting the reports required for each market and product and with planning the appropriate reporting periods, data lock points, and submission dates for each regulatory authority.
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Signal Management
In the last few years signal management has caught the attention of regulatory authorities, especially in the context of the exponential rise in data volume and the change in the type of sources. At Med Communications, the Pharmacovigilance (PV) team is constantly refining their skills and technologies to provide our clients with state-of-the-art methodologies for signal detection and management activities.
Med Communications’ signal management processes are focused on the review of aggregate data from all sources, the analysis of individual case safety reports (ICSRs), and the impact of emerging signals on the risk-benefit profile of the product. Our team applies a comprehensive approach to optimize signal detection and management activities, finding efficiencies and leveraging the appropriate methods without compromising quality. Our best practice-based process takes into account the characteristics of our clients’ portfolios and includes the most effective methods to their data sets.
Our PV team provides oversight, reviews signals, and offers valuable recommendations. We perform routine analysis and identification of potential signals, signal validation, confirmation, signal analysis, and prioritization, as well as signal assessment and recommendations for action, in accordance with applicable regulations (Good Pharmacovigilance Practices [GVP]—Module IX, FDA’s Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, CIOMS Working Group VIII recommendations, etc).
Through our expertise and clearly defined process, applying consistent signal evaluation and documentation methods, validated templates, and a well-established decision process, we provide an audit-ready environment.
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Pharmacovigilance Consulting Services
Pharmacovigilance (PV) regulatory requirements are constantly evolving. At the same time, the volume and complexity of collected safety data continue to increase, coming from an expanding variety of sources and shifting rapidly.
The experienced team of PV professionals at Med Communications can provide companies in the biomedical industry with the support they need for navigating this complex and dynamic environment, ensuring full compliance with regulations across all markets and streamlining the process of managing safety data. Our knowledge spans across various therapeutic areas and geographical regions and all phases of product development.
Building on years of hands-on experience and leveraging a well-established quality management system, PV processes, and appropriate digital tools, our PV professionals can help companies establish a fit-for-purpose PV system, on time and on budget.
We can work with you to optimize your PV system and processes by helping you:
- prepare standard operating procedures (SOPs), working instructions and handling guides, templates, trackers, job descriptions, training plans, and aggregate reports
- perform literature screening and full safety signal evaluation and documentation, in compliance with applicable guidelines
- prepare responses to requests coming from regulatory authorities
- perform medical review of safety data.
We can also provide guidance and support during audits and regulatory inspections, write and implement safety data exchange agreements with corporate partners, offer drug safety database support, and assist with vendor selection.
Our project leaders, dedicated senior PV professionals, handle your PV project end to end and serve as your point of contact, applying excellent communication and project management skills.Working with our team of PV professionals can help elevate your business by improving safety and compliance standards and streamlining PV processes. This, in turn, can help you save time and money by allowing your in-house experts to adopt a more strategic role to improve the safety profile of your products.
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Pharmacovigilance System Master File (PSMF)
Marketing authorization holders are required to establish or to have access to a pharmacovigilance (PV) system that covers all PV activities. A PV system needs to clearly show the organization of the roles and responsibilities involved and include the activities of collection and processing of safety information, reporting to regulatory authorities, signal detection, and risk minimization. These PV activities and processes need to be described in standard operating procedure (SOP) documents that become part of the PV Quality Management System (QMS).
Since 2012, a detailed document, titled the Pharmacovigilance System Master File (PSMF), has been required in the European Union (EU)/European Economic Area (EEA) to describe a company’s PV system and its associated QMS. The PSMF must indicate all PV activities and stakeholders involved, and it must be continuously updated. Several other countries around the world also require a PSMF or a similar document, which may have country-specific requirements.
At Med Communications we understand that the PSMF can be a challenging document to create and maintain and that there are no workarounds. Our PV professionals have the tools, templates, and accelerators to quickly and efficiently help our clients establish a complete and compliant PSMF. We take on this responsibility for our clients, working closely with them to collect the required information, write the main document and annexes, and maintain the PSMF over time within defined review cycles. We develop the PSMF based on specific local requirements, thereby helping our clients expand their businesses.
-
PV Support for Clinical Trials
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Literature Surveillance
The Med Communications Pharmacovigilance (PV) department provides a dedicated team for scientific literature surveillance activities. In the United States, literature surveillance is required from the point at which a medicinal product receives marketing authorization. In Europe, weekly surveillance of the worldwide scientific and medical literature is required from the moment the marketing authorization request is submitted to the European Medicines Agency (EMA). We also offer literature surveillance for products in clinical trial stages that is tailored to each client’s needs and expectations.
Our literature surveillance support includes retrieval, assessment, and case processing of individual case reports from the scientific literature. We provide weekly reports regarding activities in the literature and the cases that have been retrieved for entry into the safety database and reporting to the regulatory authorities. In addition, we track relevant aggregate data and reports of special situations that are included in periodic safety update reports (PSUR) or for assessment during signal detection activities.
Our team has years of experience in the configuration of literature search terms for different medicinal products, including medical devices. We use online Embase and Medline databases for our standard literature search analyses. We also use a compliant software tool to track and retain all information pertaining to safety data received from the literature. We work in accordance with the Guidelines on Good Pharmacovigilance Practices (GVP) – Module VI and can assure compliance and audit readiness for our clients.
-
Risk Management Plans (RMP)
Case Processing
At Med Communications, we provide full support for pharmacovigilance (PV) projects—from all phases of clinical trials, over spontaneous and solicited post-marketing individual case safety reports (ICSR), to patient support programs, pregnancy registries, and scientific and medical literature reports. We offer our clients complete end-to-end workflow management for their PV activities, including collection, processing, medical evaluation, and single case reporting of adverse events.
Our PV team includes professionals from various medical, pharmaceutical, and academic backgrounds who together offer a broad range of experience and knowledge in the different case processing areas. We assess the validity and seriousness of incoming cases and ensure the timelines for submission to regulatory authorities are met. At the core of case processing, we determine causality as well as listedness according to the reference safety information of the product. In addition to routine case reports of adverse events, we also process special situations, such as pregnancy, overdose, abuse, misuse, lack of effect, and medication errors.
We handle compliant submissions of single cases following the E2B R2 and R3 standards via industry standard gateways. We use state-of-the-art database software, such as Argus and SafetyEasy, to process and report cases to regulatory authorities. Our expertise includes working within the regulatory environments of the United States, with the Food and Drug Administration (FDA), and Europe, with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA), as well as other regulatory agencies worldwide. With a functional PV system in place, our depth of experience gives us the unique opportunity not only to offer our clients support in the markets within which their products are already available, but also to assist during expansion into new markets.
In addition to processing and submitting cases in a high-quality and compliant manner, we conduct reconciliation with teams in other non-PV functions, such as medical information, study teams, quality assurance teams, and other business partners.
Aggregate Reports
Aggregate reports provide periodic review of safety data in a global and cumulative way instead of looking at individual cases. While the concept is simple, the process can become complex to manage. To understand the benefit-risk profile of a product, the process requires the collection and assessment of safety data, as well as handling the necessary aggregate reports across a product’s lifecycle in various markets.
The Med Communications Pharmacovigilance (PV) team provides complete end-to-end management of all aggregate report types including, but not limited to, the Periodic Adverse Drug Experience Report (PADER or PAER); the Periodic Benefit Risk Evaluation Report (PBRER); the legacy Periodic Safety Update Report (PSUR), which is still used in some markets; and Investigational New Drug (IND) Annual Reports, especially where there is no Development Safety Update Report (DSUR) waiver available. Our PV services include periodic submission of individual case safety reports (ICSRs) to the appropriate regulatory authorities in support of the aggregate reports. Our PV team can also handle ad hoc report requests, such as Suspected Unexpected Serious Adverse Reaction (SUSAR)/Serious Adverse Event (SAE)/Adverse Event (AE) line listings, AE summary tabulations, and CIOMS II line listings, for clients and regulatory authorities.
Aggregate reports project management assists clients with templates, data retrieval/requests, the review process, and timelines to facilitate the contribution of the different stakeholders involved in the process and to assure compliance with submission deadlines. To analyze the data and draft the content of the required reports, our experienced PV professionals query the safety database to retrieve the necessary data and listings to be analyzed and review the additional information provided by the client. As a standard to the aggregate reports process, the PV team employs internal quality and medical reviews before submitting the reports to the client for their review and approval.
Our PV team will use their expertise and all available tools to assist clients with forecasting the reports required for each market and product and with planning the appropriate reporting periods, data lock points, and submission dates for each regulatory authority.
Signal Management
In the last few years signal management has caught the attention of regulatory authorities, especially in the context of the exponential rise in data volume and the change in the type of sources. At Med Communications, the Pharmacovigilance (PV) team is constantly refining their skills and technologies to provide our clients with state-of-the-art methodologies for signal detection and management activities.
Med Communications’ signal management processes are focused on the review of aggregate data from all sources, the analysis of individual case safety reports (ICSRs), and the impact of emerging signals on the risk-benefit profile of the product. Our team applies a comprehensive approach to optimize signal detection and management activities, finding efficiencies and leveraging the appropriate methods without compromising quality. Our best practice-based process takes into account the characteristics of our clients’ portfolios and includes the most effective methods to their data sets.
Our PV team provides oversight, reviews signals, and offers valuable recommendations. We perform routine analysis and identification of potential signals, signal validation, confirmation, signal analysis, and prioritization, as well as signal assessment and recommendations for action, in accordance with applicable regulations (Good Pharmacovigilance Practices [GVP]—Module IX, FDA’s Guidance for Industry Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment, CIOMS Working Group VIII recommendations, etc).
Through our expertise and clearly defined process, applying consistent signal evaluation and documentation methods, validated templates, and a well-established decision process, we provide an audit-ready environment.
Pharmacovigilance Consulting Services
Pharmacovigilance (PV) regulatory requirements are constantly evolving. At the same time, the volume and complexity of collected safety data continue to increase, coming from an expanding variety of sources and shifting rapidly.
The experienced team of PV professionals at Med Communications can provide companies in the biomedical industry with the support they need for navigating this complex and dynamic environment, ensuring full compliance with regulations across all markets and streamlining the process of managing safety data. Our knowledge spans across various therapeutic areas and geographical regions and all phases of product development.
Building on years of hands-on experience and leveraging a well-established quality management system, PV processes, and appropriate digital tools, our PV professionals can help companies establish a fit-for-purpose PV system, on time and on budget.
We can work with you to optimize your PV system and processes by helping you:
- prepare standard operating procedures (SOPs), working instructions and handling guides, templates, trackers, job descriptions, training plans, and aggregate reports
- perform literature screening and full safety signal evaluation and documentation, in compliance with applicable guidelines
- prepare responses to requests coming from regulatory authorities
- perform medical review of safety data.
We can also provide guidance and support during audits and regulatory inspections, write and implement safety data exchange agreements with corporate partners, offer drug safety database support, and assist with vendor selection.
Our project leaders, dedicated senior PV professionals, handle your PV project end to end and serve as your point of contact, applying excellent communication and project management skills.
Working with our team of PV professionals can help elevate your business by improving safety and compliance standards and streamlining PV processes. This, in turn, can help you save time and money by allowing your in-house experts to adopt a more strategic role to improve the safety profile of your products.
Pharmacovigilance System Master File (PSMF)
Marketing authorization holders are required to establish or to have access to a pharmacovigilance (PV) system that covers all PV activities. A PV system needs to clearly show the organization of the roles and responsibilities involved and include the activities of collection and processing of safety information, reporting to regulatory authorities, signal detection, and risk minimization. These PV activities and processes need to be described in standard operating procedure (SOP) documents that become part of the PV Quality Management System (QMS).
Since 2012, a detailed document, titled the Pharmacovigilance System Master File (PSMF), has been required in the European Union (EU)/European Economic Area (EEA) to describe a company’s PV system and its associated QMS. The PSMF must indicate all PV activities and stakeholders involved, and it must be continuously updated. Several other countries around the world also require a PSMF or a similar document, which may have country-specific requirements.
At Med Communications we understand that the PSMF can be a challenging document to create and maintain and that there are no workarounds. Our PV professionals have the tools, templates, and accelerators to quickly and efficiently help our clients establish a complete and compliant PSMF. We take on this responsibility for our clients, working closely with them to collect the required information, write the main document and annexes, and maintain the PSMF over time within defined review cycles. We develop the PSMF based on specific local requirements, thereby helping our clients expand their businesses.
PV Support for Clinical Trials
Literature Surveillance
The Med Communications Pharmacovigilance (PV) department provides a dedicated team for scientific literature surveillance activities. In the United States, literature surveillance is required from the point at which a medicinal product receives marketing authorization. In Europe, weekly surveillance of the worldwide scientific and medical literature is required from the moment the marketing authorization request is submitted to the European Medicines Agency (EMA). We also offer literature surveillance for products in clinical trial stages that is tailored to each client’s needs and expectations.
Our literature surveillance support includes retrieval, assessment, and case processing of individual case reports from the scientific literature. We provide weekly reports regarding activities in the literature and the cases that have been retrieved for entry into the safety database and reporting to the regulatory authorities. In addition, we track relevant aggregate data and reports of special situations that are included in periodic safety update reports (PSUR) or for assessment during signal detection activities.
Our team has years of experience in the configuration of literature search terms for different medicinal products, including medical devices. We use online Embase and Medline databases for our standard literature search analyses. We also use a compliant software tool to track and retain all information pertaining to safety data received from the literature. We work in accordance with the Guidelines on Good Pharmacovigilance Practices (GVP) – Module VI and can assure compliance and audit readiness for our clients.
Risk Management Plans (RMP)
For more information on pharmacovigilance and risk management, click the following links.