pharmacovigilance
Industry leading pharmacovigilance solutions from clinical development through post-approval.
Pharmacovigilance Services
How do you choose a Pharmacovigilance (PV) provider? The first step is to focus on the basics of quality, efficiency, and compliance, key factors visible in most every program. The next level involves analyzing how the team responds to your individual needs and ad hoc requests, such as identifying the options available for more unusual projects.
Next, is assessing the culture and "the fit" for this long-term partnership. It’s important to be understood and see eye-to-eye. After all of that, true success in finding the best pharmacovigilance ally requires a higher-level appraisal to see how the PV group functions when you're not even looking.
Are they moving forward without hesitation to be ready for a potential expedited submission? Are efficiency ideas shared proactively with clients? Is there an awareness of upcoming regulatory changes and how they might affect your project?
Ask us the questions. Let ProPharma show you the way we believe every client should be treated — as if their project were our only project.
Pharmacovigilance Solutions
Whether the path ahead includes a first-in-human investigative trial or global product approval, we’re here to help. From clinical development through post-marketing surveillance, your team can rely on our industry-leading PV specialists providing a full suite of services to ensure your PV system fulfills regional and global regulations, and continuously monitors the safety of your products.
ProPharma offers stand-alone contracts utilizing our myriad PV services or integration with global Clinical Research Services, Medical Information, or Regulatory services.
Clinical Pharmacovigilance
The early stages of a clinical program can be costly, trying to determine the services to trim down and where to really invest. Our solution is a simple yet scalable model starting with the basics: a safety database that can go the distance from clinical studies into post-marketing, a project team that is trained to understand the safety profile of the product and the sponsor’s motivations, and sound regulatory intelligence to navigate the guidances and requirements.
As the global reach and the complexity of the program grows, so too do the possible services, including literature search and review, custom database reports, or signal management. We share your cost concerns and have created options for many of our services from database access to Global Safety Plans—each with different price tags depending on the level of service chosen. You want to choose where to trim down and where to invest, and we want to help.
Post-marketing Pharmacovigilance
Post-marketing pharmacovigilance programs should not be handled applying a one-size-fits-all mentality. Requirements may look very different depending on the country or region in which a marketing authorization is held. The addition of business partners may create the need to write and maintain a safety data exchange agreement or a PV agreement.
Changes to the safety profile of the product may require a more robust signal detection program to be implemented. A health authority may require a post-authorization safety study or a Risk Evaluation and Mitigation Strategy. Whichever way the life- cycle of your product takes you, ProPharma is here to support all of your needs. From our Benefit-Risk team to our QPPV office. Monitoring the safety of our client’s products, it’s what we do every day.
Safety Systems
The Pharmacovigilance System Master File (PSMF) describes the PV system of the Marketing Authorization Holder (MAH) and is a legal requirement for MAHs to maintain and make available to Health Authorities . Prior to inspections, Health Authorities routinely request this document and it can also be requested on an ad hoc basis. Information is included from many stakeholders including Quality Assurance, Regulatory Affairs, and all areas of PV, so keeping the PSMF up-to date is a critical task. Using well-honed processes, standardized templates, and experienced staff, ProPharma can support you with this activity.
The Risk Management Plan (RMP) or Risk Evaluation and Mitigation Strategy (REMS) describes the PV system for mitigating risk in a program. These documents identify, characterize, and work to minimize the significant risks of a medicinal product. The overall aim of any risk management program is to ensure that the benefits of the medicinal product exceed the risks by the greatest achievable margin, and here’s where ProPharma can help. Our team of experts can support the preparation and maintenance of your RMP or take over the preparation and maintenance altogether. Our experience extends to the preparation of RMPs for well-established products, generics, innovators, biosimilars, as well as fixed combination products.
Talk to an ExpertQPPV Office
Appointing an experienced Qualified Person for Pharmacovigilance (QPPV), Local Person for Pharmacovigilance (LPPV), and deputy QPPV/LPPV can require considerable time and resources.
Although the requirements and responsibilities of a QPPV are specified in EU and UK legislation, LPPVs are subject to their own national legislation (e.g., the Graduated Plan Officer "Stufenplanbeauftragter" for Germany), which can also be daunting. As a global pharmacovigilance provider, ProPharma can advise you on the varied requirements for QPPVs and LPPVs to determine the services that will accommodate your business needs and ensure compliance with the pharmacovigilance legislation unique to each location.
Once you’ve identified your requirements, ProPharma can provide appropriately qualified and experienced QPPVs, LPPVs, and deputies globally. We have a world-wide network of QPPVs and LPPVs to serve you with their expertise from Europe to Australia and in more than 50 countries.
Through simple and scalable solutions, we provide tiered options and customized services to fit your needs. Contact us to learn more about our QPPV and LPPV services.
Explore our QPPV Services
Role of the EU QPPV
Every Marketing Authorization Holder (MAH) in Europe has an obligation to establish a pharmacovigilance (PV) system for the fulfillment of PV tasks for its products. When setting up a PV system in Europe, the MAH must appoint an EU QPPV to establish and maintain the MAH’s PV system. In addition to the establishment and oversight of the PV system, the QPPV also has several legislative responsibilities.
Responsibilities of the EU QPPV include:
- Establish and maintain the MAH’s PV system
- Monitor the safety of the MAH’s drug products
- Coordinate actions to stay compliant with local legislation
- Serve as the 24/7 point of contact for Competent Authorities
- Conduct audits and inspections to ensure compliance with EU regulations
Role of an LPPV
In addition, many European and other countries legally require a Local Person for Pharmacovigilance (LPPV) at a country level who may report to the EU QPPV (e.g., for Germany a Stufenplanbeauftragter is required). Although the requirements and responsibilities of an EU QPPV are specified in EU legislation, LPPVs are subject to their own national legislation.
Some QPPVs may have their own network of LPPVs to help fulfill local requirements. As a global pharmacovigilance provider, ProPharma can advise you about the various important requirements for EU QPPVs and LPPVs, to ensure you have the right resources in place to fully comply with the regulations for your PV system in Europe.
Get Expert Guidance Managing Legislation Requirements
ProPharma can support your organization through the provision of appropriately qualified and experienced QPPVs, LPPVs, and deputies.
ProPharma’s experts can advise you about the different roles and responsibilities of the EU QPPVs and LPPVs and offer services that can accommodate your business needs and ensure compliance with the pharmacovigilance legislation unique to each location. We have a team of local persons available to fulfill these positions and strengthen your country PV operations as your company grows. Contact us to learn more about our QPPV and LPPV services.
Case Management
At ProPharma, our teams of clinical and post-marketing Pharmacovigilance specialists provide subject matter expertise and comprehensive case processing services that are customized to meet the needs of the client and PV system. We start with the fundamentals of quality, compliance, and efficiency enabling us to build the program you want rooted in the requirements you need.
Case processing at ProPharma includes clinical trial serious adverse events (SAEs), adverse events of special interest (AESI), pregnancies, serious and non-serious spontaneous or solicited cases, legacy cases, literature search cases, and social media cases. The case management process starts with case intake, data entry, MedDRA and WHO Drug coding, followed by narrative writing based on a template approved by the client or sponsor, quality control, medical review, follow up, and reconciliation. Case processing and quality review activities go hand-in-hand, so we pay particular attention to timelines, industry guidelines, and submission requirements for global health authorities.
We offer our clients a fully compliant and validated global safety database as a single repository for the myriad events reported throughout the lifecycle of a product. The Argus platform includes appropriate backup, security measures, business continuity, and disaster recovery procedures and our long history of compliance involves processes and systems which are regularly audited. A global safety database promotes convenience while drafting an Analysis of Similar Events, ease in looking across the multiple datasets involved in aggregate reports and becomes a single source of truth for a product’s safety data.
Speak with our highly skilled data migration team about the options available for combining all of your safety data in one permanent home.
Global Literature Review
The review of worldwide scientific literature is an essential part of the ongoing safety surveillance of your product, regardless of commercial status. To ensure compliance with regulatory legislation worldwide, it is essential that global and local literature screening is regularly conducted to identify reportable ICSRs and detect potential safety signals.
Our experienced team at ProPharma can support you or assume full responsibility for these activities to ensure your PV program adheres to the global regulatory requirements. In addition, our services are cost-effective, and we are able to conduct global literature surveillance of the large bibliographical databases including Embase® and Medline®. We have extensive experience in developing robust search strategies for our clients and providing results from these searches according to an agreed upon periodicity. We can perform the review and assessment of identified literature articles, ensure the efficient and auditable documentation of results.
For Marketing Authorization Holders (MAHs) with active substances included in the EMA’s Medical Literature Monitoring (MLM) list, we perform EudraVigilance checks using the ICSR Export module based on the frequency contracted. In addition, we provide local literature searches in relevant local scientific and medical journals in countries where your product is marketed and legally required.
Signal Management
Signal management is a critical process for the proactive and timely identification of potential new safety risks for medicinal products that requires the utmost expertise. Signal management can be deployed throughout both the clinical development and post-marketing phases of the product lifecycle. Safety issues may affect the benefit-risk balance of the product, requiring updates to product labels and other steps that help protect patients from harm.
ProPharma has deep expertise across all signal management activities, including detection, validation, prioritization, and assessment. We do this using a wide range of sources (e.g., spontaneous cases, safety data from clinical trials, and noninterventional studies and literature reports). We are also fully trained and experienced in the EudraVigilance Data Analysis System (EVDAS) functionality and can support MAHs to comply with their obligations for signal detection and management. Using a variety of options, we leverage our robust knowledge to select the most efficient and effective method(s) for each product that is compliant with legislative requirements.
Talk to an ExpertPeriodic Safety Reports and Risk Management Plans
The Risk Management Plan (RMP) or Risk Evaluation and Mitigation Strategy (REMS) describes the PV system for mitigating risk in a program. These documents identify, characterize, and work to minimize the significant risks of a medicinal product. The overall aim of any risk management program is to ensure that the benefits of the medicinal product exceed the risks by the greatest achievable margin, and here’s where ProPharma can help. Our team of experts can support the preparation and maintenance of your RMP or take over the preparation and maintenance altogether. Our experience extends to the preparation of RMPs for well-established products, generics, innovators, biosimilars, as well as fixed combination products.
The preparation of Periodic Safety Reports is required throughout both the clinical development and post-marketing phases of the product lifecycle. The periodic review of safety data from relevant sources is essential for the ongoing benefit risk evaluation to ensure patients´ safety and well-being.
At ProPharma, our team works diligently to ensure compliance with applicable regulations for aggregate safety reports. We have wide-ranging experience in analyzing and evaluating data and generating required periodic reports such as:
- Periodic Safety Update Reports (PSURs) / Periodic Benefit-Risk Evaluation Reports (PBRERs),
- Periodic Adverse Drug Experience Report (PADER),
- Development Safety Update Reports (DSURs)
- Country-specific periodic reports
We also can support you in:
- Responding to Request for Information (RFI) from Regulatory Authorities
- Preparing the addendum to Clinical Overviews (ACO)
- Submission of the reports
ProPharma is staffed with highly experienced and qualified staff to ensure a timely development of Periodic Safety Reports and RMPs with high quality.
Global ICSR Submissions
ProPharma recognizes the critical nature of accurate and on-time submissions to health authorities, Institutional Review Boards (IRBs), and Ethics Committees (ECs). We perform ICSR submissions including MedWatch, CIOMS I, E2B(R2), and E2B(R3) reports for various product types including approved and non-approved drugs, biologics, devices, vaccines, dietary supplements, homeopathic products, and natural health products. ICSRs are exchanged with clients and Sponsors for review and comment before the final submission, if requested. Clients and Sponsors also maintain oversight of case processing and reporting activities ahead of the submission via Case Explorer, a read-only application that allows for real-time database querying and review of database information within individual cases. Clients and sponsors who wish to maintain oversight of case processing within the safety database may also do so via read-only access as part of individual user implementation and security procedures.
Each month, compliance metrics are generated from the safety database submission reports for all pharmacovigilance and clinical safety programs and shared with all interested clients. ProPharma is proud to post a greater than 99% compliance rate, successfully submitting over 2,000 ICSRs per month to health authorities and business partners on behalf of post-marketing pharmacovigilance clients and clinical safety Sponsors.
Pharmacovigilance Experts
News & Insights
September 25, 2023
DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...
September 21, 2023
Meet the Expert: Kamila Rocha
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
September 20, 2023
Clinical Pharmacology Considerations for Peptide Drug Products, September 2023
The FDA has recently issued this draft guidance to address clinical pharmacology considerations for peptide drug products. A peptide is any polymer with 40 or fewer amino acids. These products fall...
News & Insights
September 13, 2023
ProPharma Introduces ClinCHAT, a Solution to Unleash the Power of Real-World Evidence with Conversational AI
Raleigh, NC, September 13, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 30, 2023
ProPharma Expands Regulatory Sciences Team in the Japan and Asia-Pacific Region with Addition of Neama Baho
RALEIGH, NC, August 30, 2023: ProPharma Group (ProPharma), the leading global provider of regulatory, clinical and compliance services for the life sciences industry, and a portfolio company of...
August 15, 2023
ProPharma Recognized by Inc. 5000 List of America’s Fastest-Growing Companies
ProPharma Recognized on the Inc. 5000 List of America’s Fastest-Growing Companies After a year of Growth and Innovation, ProPharma achieved its highest rank in 20+ year history. RALEIGH, NC, August...
Complex Needs Require Custom Solutions
ProPharma builds solutions at the intersection of innovation and flexibility. We’re here to offer a custom alternative that fits your unique needs. Standout solutions scaled to your size.