Building and maintaining an effective pharmacovigilance system is critical for ensuring the safety of your products. Our services in this area include, but are not limited to:
Creating and updating SOPs and working practices to support all PV activities within your organization.|
Authoring and maintaining agreements to ensure accurate and timely safety data exchange.
Development and governance of labeling committees and management of safety variations and urgent safety restrictions.
Consultancy support for safety database due diligence, set-up, validation, and data migration activities.
Management and support of safety committees to oversee safety signal management and risk minimization activities.
Design and/or maintenance of quality management systems to ensure compliance and efficiency in PV activities.
Managing day-to-day PV activities can be complex and resource-intensive. Our experienced consultants provide comprehensive support, ensuring all aspects of your PV operations run smoothly. Our services in this area include, but are not limited to:
Support for managing safety information from product quality complaints, medical inquiries, and solicited activities (e.g., registries, market research, patient support programs, company-sponsored social media activities).
Development of adverse event and pregnancy forms. Processing, analysis, reporting, and follow-up on adverse events as well as AE reporting requirements training.
Review and input into clinical trial protocols, investigator brochures, clinical study reports, safety management plans, and medical monitoring plans.
Conducting on-site or remote audits of internal global and affiliate PV departments, as well as audits of contractual partners and providers.
Providing medical information support and managing medical inquiries.
Preparation of global aggregate safety reports, including DSUR/ASR, PSUR/PBRER/PADER.
Our resources also provide strategic oversight and specialized expertise to enhance your PV system. Our services in this area include, but are not limited to:
Detection, evaluation, and management of safety signals to identify and mitigate potential risks.
Development and maintenance of risk management plans and risk evaluation and mitigation strategies.
Providing clear and effective communications with competent authorities regarding benefit-risk assessments.
On-site or remote support before, during, and after regulatory inspections to ensure compliance and readiness, including CAPA plan development and management, and through completion.
High-level strategic PV assessment, analysis, and oversight to ensure your PV system is robust, compliant, and responsive to evolving safety needs.
Management of safety variations and implementation of urgent safety restrictions to ensure ongoing product safety.
Learn how The FDA Group partnered with a large clinical service company to manage its QMS remediation efforts and fulfill long-term staffing assignments for two vital roles in the management of the company’s quality and pharmacovigilance functions. This case study demonstrates the value of our convenient, cost-effective workforce model that circumvents the administrative costs and burdens of traditional hiring.
Put your projects in the hands of qualified third-party experts. Project-based consulting engagements are executed by an individual or team of specialized resources. Our dedicated project management team works closely with your leadership team to establish and track project milestones, schedule activities, guide resources, and report on success.
Get contracted full-time consultant (FTC) staffing support and functional outsourcing for specified or open-ended engagement durations—a flexible, convenient alternative to traditional hiring. Fill staffing assignments, bridge gaps, and fill interim and even long-term roles. Contracted resources can work on-site or off-site as a functional extension of your team.
We rapidly identify and place direct hire candidates in a variety of positions and job functions. Our recruiters draw on extensive industry expertise to fully understand your hiring needs and conduct a rigorous identification and screening process to provide a shortlist of highly-qualified candidates, especially in specialized, competitive areas.
The Functional Service Program (FSP) is a bundled engagement option that consolidates your externally-sourced projects through a single vendor in The FDA Group. By streamlining vendor management, our FSP eliminates inefficiency, reduces budget overruns, and provides high-quality services from the industry's top talent. Discounts scale with the size and duration of the service package and include a Total Quality Guarantee to ensure reliable service.
