,Pharmacovigilance Services - Overview
Pharmacovigilance and drug safety are critical functions within life sciences organizations. Pharmacovigilance (PV), also known as safety PV, pertains to two major aspects of any drug formulation or medical intervention: safety and efficacy. The primary goal is to comprehensively understand its safety profile and if a drug is effective. Among the many pharmacovigilance companies, choosing the right partner is crucial. The spectrum of PV is generally divided into operations, surveillance, databases and systems, and Qualified Person for Pharmacovigilance (QPPV).
Often, companies choose to outsource their end-to-end drug safety and pharmacovigilance services for two main reasons: the high cost of internalizing all functions and the need for internal resources to focus on strategic initiatives.
When selecting a partner from the various Pharmacovigilance service providers, it is important that they offer comprehensive support and have the experience to manage such a critical task. Freyr has established itself as a leading provider of pharmacovigilance services, offering a complete spectrum of solutions.
Freyr’s Pharmacovigilance Services
Pharmacovigilance Services
- A single point of contact for the entire range of safety services, including ICSR, aggregate reports, QPPV services, US agent services, signal detection and management, risk management, database solutions including data migration, and region-specific pharmacovigilance services such as LPPV.
- Expertise in medical evaluation across pharmacovigilance activities such as medical review of ICSRs, signals, periodic reports and benefit risk management.
- Management of initial submission kick-offs to Health Authorities (HA) and handling of HA queries.
- In-depth drug safety knowledge, perfectly integrated with the required IT capabilities to provide comprehensive pharmacovigilance solutions.
- Expertise in ICSR case management, including case triage/book-in, case processing, narrative writing, medical review, quality control, and submissions. These are core components of our pharmacovigilance services.
- Staff with significant experience in managing standard and customized pharmacovigilance safety databases like Aris G, Oracle Argus, AERS, FAERS, SCEPTRE, Empirica Trace, Sapphire, and Clintrac.
- Expertise in writing aggregate safety documents per various health authorities’ requirements, such as PSURs, PBRERs, DSURs, PADERs, ASRs, RMPs, and REMS.
- Our pharmacovigilance services include setting up systems and processes such as PV database evaluation and validation, harmonization, SOP writing, and employee training.
- Experience in conducting mock audits, inspection-readiness training, and support in preparing Corrective and Preventive Action (CAPA) and remediation activities.
- Experience in tracking safety variations and Pharmacovigilance System Master File (PSMF) compliance.
- Defined processes for thorough scientific, medical, editorial, and quality control reviews ensure our pharmacovigilance services meet the highest standards.
- Timely delivery with the highest quality.
- Expert program and project management support to maintain compliance.
- Competent Pharmacovigilance Services from pre approval to post market.
- Expertise in niche activities such as RMP, signal management and aggregate reports.
- Agility and experience of working with manual and automated procedures.
- Global presence with offices in India, EU, LATAM and Japan.
Pharmacovigilance
