Pharmacovigilance
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Pharmacovigilance
Pharmacovigilance Services
Patient safety doesn't end when a product reaches the market — it's an ongoing responsibility. Rexera Pharma's pharmacovigilance function tracks the safety profile of every product we distribute, working in step with our regulatory team to keep partners compliant and informed as products move through their full lifecycle.
Case Processing & Safety Data Management
- •Receipt, triage, and processing of Individual Case Safety Reports (ICSRs)
- •Data entry, narrative writing, and medical coding using MedDRA / WHO-DD
- •Seriousness and causality assessment for every reported case
Aggregate Reporting
Preparation of periodic safety reports, including:
- •Periodic Safety Update Reports (PSURs)
- •Periodic Benefit-Risk Evaluation Reports (PBRERs)
- •Development Safety Update Reports (DSURs)
- •Annual reports for investigational products
- •Risk-benefit evaluation and mitigation recommendations
Risk Management Plan (RMP) Development
- •Development and review of RMPs tailored to each product's safety profile
- •Defining and tracking effective risk minimization measures
Pharmacovigilance System Master File (PSMF)
- •Creation and maintenance of PSMFs in line with EU regulations
- •Ongoing updates as regulatory guidelines evolve
Safety Database Setup & Maintenance
- •Configuring safety databases to global standards (EudraVigilance, FDA, etc.)
- •Continuous monitoring and troubleshooting to keep systems running smoothly
- •Ensuring timely reporting to authorities and business partners
Regulatory Submissions
- •Submission of adverse event reports, including SUSARs and expedited reports
- •Managing submissions through portals such as EudraVigilance and FDA FAERS
Safety Data Exchange Agreements (SDEAs)
- •Drafting and managing SDEAs with business partners
- •Defining clear roles and responsibilities for shared PV activities
Literature Monitoring & Signal Detection
- •Systematic review of scientific literature for adverse event mentions
- •Identifying and escalating potential safety signals from published data
Audits & Inspections Support
- •Preparation for regulatory audits and inspections
- •Internal audits to confirm alignment with Good Pharmacovigilance Practices (GVP)
Medical Information Support
- •Scientific and medical responses to queries from healthcare professionals
- •Accurate documentation of every medical inquiry received
Our pharmacovigilance team works with the same discretion and rigor we apply to every part of the product lifecycle — so partners can focus on growth while we manage the ongoing complexity of global safety monitoring.