Pharmacovigilance & Clinical Safety Solutions

Leading the Industry with Comprehensive Pharmacovigilance from Clinical Development to Post-Approval.

ATI Life Science Staffing

Pharmacovigilance Services

Selecting a Pharmacovigilance (PV) provider goes beyond the basic criteria of quality, efficiency, and compliance. The key lies in finding a team that resonates with your unique needs, responds to ad hoc requests, and is proactive in their approach. ATI Life Science Staffing excels in providing tailor-made PV solutions, ensuring seamless integration with your project demands, whether it’s handling unusual projects or keeping abreast of regulatory changes. Our commitment is to treat each project with unparalleled attention and dedication as if it were our only focus.

Clinical Pharmacovigilance

In the critical early stages of clinical programs, balancing cost-effectiveness with necessary investments can be challenging. ATI Life Science Staffing’s solution is a scalable model that evolves with your program. We begin with the essentials: a robust safety database, a project team attuned to your product’s safety profile and motivations, and solid regulatory intelligence. As your program’s reach and complexity grow, we adapt by offering expanded services such as literature review, custom reports, or signal management. Our flexible service models are designed to align with your budgetary constraints and investment priorities.

Post-marketing Pharmacovigilance

Post-marketing pharmacovigilance demands a bespoke approach. ATI Life Science Staffing understands that requirements vary significantly across different regions and market authorizations. We offer comprehensive support for every twist and turn in your product’s lifecycle, from Benefit-Risk assessment to QPPV office management. Our focus is on ensuring the continuous monitoring and safety of our clients’ products.

Safety Systems

Maintaining an up-to-date Pharmacovigilance System Master File (PSMF) is a critical legal requirement. ATI Life Science Staffing employs streamlined processes and expert staff to keep your PSMF current and compliant. Similarly, we offer comprehensive support in developing and maintaining Risk Management Plans (RMPs) or Risk Evaluation and Mitigation Strategies (REMS), focusing on minimizing the significant risks of medicinal products.

QPPV Office

The appointment of a Qualified Person for Pharmacovigilance (QPPV) and a Local Person for Pharmacovigilance (LPPV) is a resource-intensive task. ATI Life Science Staffing provides guidance on the varied requirements for QPPVs and LPPVs and offers qualified professionals to fulfill these roles globally. Our network of QPPVs and LPPVs extends across over 50 countries, ensuring compliance with pharmacovigilance legislation in each location.

Case Management

ATI Life Science Staffing’s case management services are tailored to meet the unique needs of your PV system, focusing on quality, compliance, and efficiency. Our services include processing a wide array of cases, from clinical trial adverse events to post-marketing reports. We utilize a fully compliant global safety database, ensuring a single repository for all safety data, facilitating efficient data analysis and reporting.

Global Literature Review

Global literature review is a crucial component of safety surveillance. ATI Life Science Staffing’s team efficiently conducts global and local literature screenings to identify reportable cases and detect potential safety signals. Our cost-effective services encompass extensive database searches and comprehensive assessment of literature articles, ensuring compliance with global regulatory requirements.

Signal Management

Signal management is vital for identifying new safety risks. ATI Life Science Staffing provides expertise in all aspects of signal management, including detection, validation, prioritization, and assessment, using various sources and tools to ensure legislative compliance and patient safety.

Periodic Safety Reports and Risk Management Plans

ATI Life Science Staffing’s team excels in the preparation of periodic safety reports and risk management plans, ensuring ongoing benefit-risk evaluation and patient safety. Our experience spans a broad range of products and report types, maintaining compliance with global regulations.

Global ICSR Submissions

Timely and accurate submissions to health authorities are critical. ATI Life Science Staffing boasts a high compliance rate in ICSR submissions, providing transparency and oversight in case processing and reporting activities. Our commitment to excellence is reflected in our consistent achievement of over 99% compliance in submissions.

At ATI Life Science Staffing, we offer a comprehensive suite of pharmacovigilance services, ensuring that every aspect of your product’s safety monitoring is managed with the highest standards of quality and compliance. Our approach is not just about fulfilling requirements; it’s about partnering with you to safeguard patient health and achieve your project goals.

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Elevate your staffing experience with ATI Life Science Staffing. Contact us now to experience excellence in Life Sciences staffing, where precision meets passion, and success is the ultimate destination.

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