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26_unidad_de_farmacovigilancia_para_la_industria

Pharmacovigilance Unit Service for Pharma

Safeguarding Health, Ensuring Safety

Pharmacovigilance is a critical function in the pharmaceutical industry, focused on monitoring and evaluating the safety of medicinal products throughout their lifecycle.

At Pro Pharma Research Organization, our Pharmacovigilance Unit offers comprehensive services to pharmaceutical companies, ensuring the safety and well-being of patients while maintaining regulatory compliance.

Service overview

Adverse Event Reporting and Management
Timely and accurate collection, assessment, and reporting of adverse events associated with pharmaceutical products to regulatory authorities.
Signal Detection and Risk Assessment
Ongoing analysis to detect potential safety signals and evaluate risks, allowing for informed decision-making and risk mitigation.
Omni / Multi-Channel Communication
Our contact center supports a wide range of communication channels, including voice calls, email, SMS, live chat, whatsapp /Telegram social media, and video conferencing. This enables customers to reach out through their preferred medium, increasing accessibility and convenience.
Regulatory Compliance
Ensuring strict adherence to local and global pharmacovigilance regulations, including timely submission of required safety reports.
Safety Data Management
Effective management of safety data from various sources, including clinical trials, post-market surveillance, and spontaneous reports.
Benefit-Risk Assessment
In-depth evaluation of the benefits and risks associated with pharmaceutical products to support regulatory submissions and label updates.
Aggregate Safety Reports
Preparation of periodic safety reports, such as Periodic Safety Update Reports (PSURs) and Development Safety Update Reports (DSURs), for regulatory compliance.
Signal Management and Evaluation
Systematic signal detection, validation, and prioritization to ensure timely response to potential safety concerns.
Risk Minimization and Mitigation Strategies
Development and implementation of risk minimization plans and strategies to enhance the safety profile of pharmaceutical products.
Literature Screening and Analysis
Comprehensive literature reviews and analysis to identify safety-relevant information and assess its impact on product safety.
Post-Market Surveillance
Continuous monitoring of products in the post-market phase to identify safety issues and ensure patient safety.
Quality Assurance and Audits
Regular quality checks, audits, and inspections to maintain the highest standards of pharmacovigilance practices.
Medical Writing and Documentation
Preparation of safety-related documents, including safety narratives, Periodic Benefit-Risk Evaluation Reports (PBRERs), and Development Risk Management Plans (RMPs).
Medical Review and Case Processing
Thorough medical review and case processing to ensure accurate assessment and reporting of adverse events.

Pharmacovigilance is a cornerstone of pharmaceutical safety, and at Pro Pharma Research Organization, we are committed to ensuring the well-being of patients and compliance with regulatory requirements. Our Pharmacovigilance Unit offers a comprehensive range of services to pharmaceutical companies, maintaining a strong focus on safety, compliance, and risk management throughout the product lifecycle. Your trust in our pharmacovigilance expertise safeguards patients' health and fosters confidence in the safety of pharmaceutical products.