Effective pharmacovigilance systems are critical to patient safety and regulatory compliance throughout a product's lifecycle. Our approach focuses on conducting thorough evaluations of your pharmacovigilance processes, documentation, and systems against current regulatory expectations. We help you identify opportunities to strengthen safety surveillance, signal detection, and reporting processes while ensuring compliance with evolving global pharmacovigilance requirements.
Our pharmacovigilance audit services include, but are certainly not limited to:
Comprehensive evaluations of pharmacovigilance systems against global regulatory requirements.
Detailed assessments of adverse event collection, processing, and reporting procedures.
Focused reviews of signal detection, evaluation, and management processes.
Verification of Pharmacovigilance System Master File contents and management.
Evaluation of scientific literature monitoring for safety information.
Assessment of safety database validation and data integrity controls.
Reviews of PV activities delegated to CROs and other service providers.
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/contractor (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.
