Drug Safety & Pharmacovigilance
TFS HealthScience pharmacovigilance experts set up, manage,
and optimize the product safety needs of our customers throughout
the entire clinical development and post-marketing journey.
Flexibility and tailored services where you need them
Pharmacovigilance (PV) activities are fundamental to both patient safety and regulatory compliance. When outsourcing some or all of your program’s PV activities, efficient, high-quality processes are necessary to ensure the collection, management and analysis of all safety data. It’s equally essential to integrate these services into your technical systems so that you have complete oversight of your safety data.
End-to-end global pharmacovigilance services
Global PV services (with local PV management) spanning all phases of clinical development, PV system set-up in support for marketing approval, and ongoing management of post-marketing patient safety in accordance with global requirements
Full suite of clinical safety services as part of full-service studies or as an outsourced safety provider across all studies (functional outsourcing): SMP development; validated safety database hosting and legacy data migration; SAE intake, processing, medical review and assessments; safety reporting to regulatory authorities IRBs/ECs, and sites worldwide; safety data analysis; and aggregate reports (e.g., DSURs and other periodic safety reports)
Specialists in supporting companies with post-approval PV requirements globally: Establishing new PV systems and associated quality systems, supporting New Drug Applications / marketing authorizations; set-up and maintenance of a validated global safety database; data migration, including integration of clinical safety data from multiple sources in preparation for post-marketing PV; and expansion into new markets (e.g., US to EU, EU to APAC). Our safety experts can provide strategic PV consulting, SOP authoring, auditing and training (including inspection-readiness training)
Operational “head office” PV activities including adverse event intake and processing; global safety reporting; XEVMPD/EV management.; literature review; safety surveillance and risk management planning (including RMPs and REMS); aggregate safety reports (e.g., ASR, PSUR/ PBRER); EU QPPV (and deputy); PV system master file (PSMF); safety automation and robotics
Provision of local affiliate safety activities, including expanding to new countries and regions or consolidation and centralization of local PV activities: medical information/call center, product quality complaint management, local case intake, worldwide PV regulatory intelligence, local qualified person (local QPPV) / local safety officer (globally, where required), local literature, local RMPs & PSMFs, and implementation of local risk management & minimization activities
TFS pharmacovigilance systems integration
Our team’s goal is to understand your requirements and develop an efficient, globally compliant, PV solution / system that operates as a seamless extension to your organization, giving you complete oversight and control of your safety data.
Establishing and operating validated global PV systems (clinical and post-marketing)
Consolidation of PV activities from multiple vendors into a single, more efficient PV system
One team, one goal
We consider every assignment a partnership. Our experienced teams work in close collaboration with you from the very beginning.
Serving as the outsourced PV department
Providing tailored PV services, including Qualified Person responsible for Pharmacovigilance (QPPV) services
Fully integrated safety services
By choosing TFS as your PV partner, you not only have access to our PV experts, but also to expertise in other areas required for the protection of patient safety.
Our safety services are fully integrated with our regulatory, medical and clinical teams, ensuring oversight from initial design through post-approval.
Quality Management Oversight
A robust Quality Management System overseen by TFS Quality Assurance for independent oversight of our safety activities underpins all TFS safety and PV services. The integrity of our systems, our team’s expertise, and the quality of data—this is the core of our offering.
We are strategically placed to provide worldwide coverage with the highest levels of compliance and cost-effective, efficient processes. Our teams ensure we have the right people to deliver the best service, with comprehensive metrics to ensure you have complete oversight of safety data and global compliance.