Pharmacovigilance Process Solutions
There is an increasing demand for precision in clinical documentation and reporting – from pre-marketing clinical procedures to adverse event reporting. Pharmacovigilance (PV) serves as a post-marketing tool to safeguard the safety of pharmaceutical products by identifying and minimizing adverse drug reactions and their related complications. WorkSure® has a well-structured PV Process Solution that is a user-friendly, regulatory-compliant, end-to-end drug safety solution.
WorkSure® PV Process Solutions is an all-in-one solution for PV intake, case processing, analytics, submission gateway, and safety signal assessment. Our PV system monitors the safety of registered pharmaceutical products and detects changes in their benefit-risk balance. Thus, it aids in precise safety data creation for different levels of the healthcare environment. Our experts help in identifying and resolving gaps in PV processes. Furthermore, we can assist in selecting and implementing the most cutting-edge and relevant digital technologies, like artificial intelligence and cloud solutions.
WorkSure® PV Process Solution complies with the “Pharmacovigilance Guidance Document for Marketing Authorization Holders of Pharmaceutical Products” released in January 2018. We leverage the latest technologies to extract and classify data, identify key entities (such as medical history, adverse events, and patient-level information), and execute medical coding. Our robust PV system includes a safety database, standard operating procedures, and a network of trained competent personnel that ensures that the final output is accurate and compliant for our clients.
Advantages of WorkSure® Pharmacovigilance Process Solutions :
- Ensuring regular safety status review meetings with stakeholders for smooth execution of the entire process with reduced overall timelines
- Combining our highly skilled team with streamlined processes and innovative tools minimizes redundancies, gaps, and delays at all steps of the PV processes
- Providing full-time troubleshooting support and integrating applications for signal detection
WorkSure® Pharmacovigilance Process Solutions :
We help the healthcare industry in establishing a PV reporting culture by introducing a simple and cost-effective PV reporting paradigm.
- Development of Safety Management Plan
- Preparation of Standard Operation Procedures (SOPs) for PV activities
- Processing, causality assessment, and medical review of safety data
- Adverse Event (AE) Reporting
- AE Review
- Serious Adverse Event (SAE) Data Reconciliation
- Reporting of Serious Adverse Reaction (SAR), Suspected Unexpected Serious Adverse Reaction (SUSAR)
- Signal detection, evaluation, and management
- Preparation and evaluation of Risk Management Plans (RMPs); Risk Evaluation and Mitigation Strategies (REMS)
- Preparation and submission of Individual Case Study Reports (ICSRs)
- Aggregate Safety Report Generation such as Periodic Safety Update Reports (PSURs), Development Safety Update Reports (DSURs)
- Literature Review and Surveillance
- Data Safety Integration, and Analysis
- Gap Analysis and Review of PV Systems and Processes
- Management of PV System Master File (PSMF)
- Maintenance of PV Safety Database for Drugs/Devices/Biologics
- Clinical Trial Safety Management
- Medical Monitoring Services
- Data Safety Monitoring Services
- Clinical PV Auditing Services