Pharmacovigilance
Pharmacovigilance (PV), a most important function also known as Drug Safety, relates to aspects of any drug formulation/medical intervention with therapeutic benefit that are safe and effective.
The pharmacovigilance services majorly divided into pharmacovigilance operations, pharmacovigilance surveillance, pharmacovigilance database and systems, and Qualified Person for Pharmacovigilance (QPPV).
When choosing your safety partner, it is important that the partner is a beacon for end-to-end safety services provisions and has the experience and the skillset to be able to handle such a huge task.
The Medical Device Reporting (MDR) regulation (21 CFR Part 803) contains mandatory requirements for manufacturers, importers, and device user facilities to report certain device-related adverse events and product problems to the FDA.
Revive, a beacon of end-to-end Regulatory service provider for Pharmacovigilance, has the experience and the skillset to be able to handle such a huge task is well-established, in line with the complete spectrum of pharmacovigilance services, which are as follows:
- Literature Management
- Pharmacovigilance Audit and Training
- Safety Database Solutions
- Regulatory Intelligence and Consulting
ADVANTAGES
- 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 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 through the 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 PV System Master File (PSMF) compliance