Pharmacovigilance Services

Minimize risk and maximize trust with Freyr’s robust pharmacovigilance solutions that comply with regulations to ensure patient safety. Navigate the drug development process with our experts to circumvent uncertainty.    

Pharmacovigilance Services - Overview

Pharmacovigilance and drug safety are important functions within life sciences companies, and hence, they require expert Pharmacovigilance Services. Pharmacovigilance (PV), also known as drug safety pharmacovigilance, relates to two (2) major aspects of any drug formulation/medical intervention with therapeutic benefit, safety, and efficacy. The first is to know whether a drug works, and the second is to decode its safety.

The spectrum of Pharmacovigilance Services is majorly divided into pharmacovigilance operations, pharmacovigilance surveillance, pharmacovigilance databases and systems, and Qualified Person for Pharmacovigilance (QPPV).

Often, companies choose to outsource end-to-end drug safety Pharmacovigilance Services from a PV specialist provider for the following two (2) reasons:

The cost of internalizing all the functions is a burden due to the unpredictable volume of incoming reports. This variability necessitates a shift-left approach to effectively manage the workload.
Internal resources need to focus on strategic initiatives over functional activities.

When choosing your safety partner, it is important that the partner is a beacon for end-to-end drug safety & Pharmacovigilance Services and has the experience and the skill set to handle such a huge task.

Freyr, as a comprehensive Regulatory service provider for pharmacovigilance & drug safety, has been well-established as a house of safety over the years, in line with the complete spectrum of Pharmacovigilance Services, which are as follows:

Freyr’s Pharmacovigilance Services

Single point of contact for the entire range of safety services, including ICSR, aggregate reports, Qualified Person Responsible for PV (QPPV) services, the US agent services, signal detection & evaluation, database migration, adverse event reconciliation, local affiliate services, and any other region-specific pharmacovigilance consulting services
Initial submission kick-offs to the HA and handling/addressing HA queries
In-depth safety knowledge, perfectly integrated with the required IT capabilities
Expertise in ICSR case management, including case triage/book-in, case processing, narrative writing, medical review, quality control, and submissions
Staff with hands-on experience in handling/managing standard and customized pharmacovigilance safety databases like Aris G, Oracle Argus, Adverse Event Reporting System (AERS), FDA's AERS (FAERS), SCEPTRE, Empirica Trace, Sapphire, Clintrac, etc.
Expertise in writing aggregate safety documents per various health authorities’ and submission requirements, such as Periodic Safety Update Reports (PSURs), Periodic Benefit Risk Evaluation Reports (PBRERs), Development Safety Update Reports (DSURs), Periodic Adverse Drug Experience Reports (PADERs), Annual Safety Reports (ASRs), Risk Management Programs (RMPs), Risk Evaluation and Mitigation Strategy (REMS), and any other country-specific reports
Expertise in setting up pharmacovigilance systems and processes such as PV database evaluation, PV database validation, harmonization, writing SOPs, and training employees per the local Regulatory requirements in various geographies
Experience in conducting mock audits, training on facing inspections, support in preparing Corrective and Preventive Action (CAPA), and remediation activities through pharmacovigilance consulting services
Extensive experience in PV process harmonization and creation of Company Core Data Sheet (CCDS) and Core Safety Information (CSI)
Experience in tracking safety variations and Pharmacovigilance System Master File (PSMF) compliance
Defined processes of thorough scientific, medical, editorial, and quality control reviews
Timely delivery with the highest quality in ensuring pharmacovigilance and drug safety
Expert program and project management support to maintain compliance and provide pharmacovigilance solutions