Pharmacovigilance is one of the most important functions within Life science companies. Pharmacovigilance (PV), also known as Drug Safety, relates to two (02) 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 safety.
The spectrum of PV services is majorly divided into Pharmacovigilance Operations, Pharmacovigilance Surveillance, Pharmacovigilance Database and Systems, and Qualified Person for Pharmacovigilance (QPPV).
Often, companies choose to outsource the end-to-end spectrum of Pharmacovigilance services to a PV specialist provider to take the complete piece -away from their plate for two reasons:
- the cost to internalise all functions is a burden as there is no fixed number of reports coming in, which means a Shift-left approach to manage 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 the complete spectrum of safety services and has the experience and the skillset to be able to handle such huge task.
Freyr, as an end-to-end provider in the PV and the Regulatory space, is well-established as a house of safety over the years, in line with the complete spectrum of PV services, which are as follows:
- 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 and Local Affiliate Services
- Initial kick-off to submissions to the HA and handling/addressing HA queries
- In-depth safety knowledge perfectly integrated with required IT capabilities
- Expertise in ICSR case management including Case Triage/Book-in, Case Processing, Narrative Writing, Medical Review, Quality Control and Submission
- Staff with hands-on experience in handling/managing standard and customized 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 as per various health authorities and submission requirements such as Periodic Safety Update Report (PSUR), Periodic Benefit Risk Evaluation Report (PBRER), Development Safety Update Report (DSURs), Periodic Adverse Drug Experience Report (PADERs), Annual Safety Report (ASRs), Risk Management Program (RMPs), Risk Evaluation and Mitigation Strategy (REMS), any other country specific reports, etc.
- Expertise in setting up PV systems and processes such as PV Database Evaluation, PV Database Validation, Harmonization, Writing SOPs, and Training Employees as 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
- 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 PV System Master File (PSMF) compliance
- Defined processes of thorough scientific, medical, editorial, and quality control review
- Timely delivery with the highest standard of quality
- Expert program and project management support to maintain compliance