Drug safety issues are evidence based and exist through more prevalent routes in this real-world situation. Pharmacovigilance systems must be in place to monitor all such drug safety issues arising out of the drug products throughout their lifecycle.
The regulatory authorities worldwide regulate all the pharma companies to ensure that a compliant PV system is implemented therein. To implement it successfully, all the pharma companies have to follow PV guidelines, in accordance with the ICH and country specific pharmacovigilance guidelines. It is now the responsibility of pharma companies being MAHs for collection, processing and forwarding the drug safety reports to the licensing authority.
Pharma Vigil comprises skilled and trained PV professionals who develop and implement customised strategies for PV and Drug safety services for the pharma companies worldwide.
Pharma Vigil Drug Safety Services can support here in establishing a fully compliant PV system and PV quality management system with the help from our expertise PV team who have rich experience in setting up the systems in the US, Canada, Europe and India. Our PV team also provides training and consultancy support to PV centres located in India and across the globe. Moreover, we have experience in writing various PV related documentation such as Aggregate reports, RMPs, PSMFs and critical SOPs to support MAHs in the US, EU, India including review of the documents.
Pharma Vigil PV Services are:
- ICSR Case Processing
- Literature Surveillance
- PV Medical Writing:
- Periodic Benefit-Risk Evaluation Reports (PBRERs)/Periodic Safety Update Reports (PSURs);
- Periodic Adverse Drug Experience Reports (PADERs);
- Developmental Safety Update Reports (DSURs);
- Risk Management Plans (RMPs) and Risk Evaluation and Mitigation Strategies (REMSs);
- Pharmacovigilance System Master Files (PSMFs);
- PV Quality Management
- PV Regulatory Inspection
- PV Auditing Service
- Standard Operating Procedures (SOPs)