At Oviya MedSafe, we understand that clear, well-organized written policies and procedures are crucial for implementing a robust quality management system in Pharmacovigilance. These documents define the goals of our clients and ensure consistency and regulatory compliance in daily operations.

We specialize in developing Pharmacovigilance-related Standard Operating Procedures (SOPs), Work Instructions, and Guides that adhere to global regulatory standards. Our approach safeguards data integrity, maintains high-quality standards, and ensures compliance with the latest industry regulations.

Additionally, we provide expert guidance on revising and updating existing procedures, helping our clients stay aligned with evolving regulatory requirements and best practices.

Pharmacovigilance regulations increasingly require companies worldwide to conduct regular, risk-based audits of their Pharmacovigilance and Quality Management Systems. These audits are essential for ensuring that safety risks are communicated effectively to regulators and healthcare professionals. The primary objective of a Pharmacovigilance audit is to evaluate the effectiveness, compliance, and alignment of systems with regulatory requirements through objective evidence.

At Oviya MedSafe, we offer expert guidance and comprehensive support for audits and mock inspections, ensuring your organization is fully prepared for regulatory reviews. Our experienced team helps mitigate risks that could impact your Pharmacovigilance and Quality Management Systems, increasing the likelihood of successful regulatory inspections.

The rapidly evolving regulatory landscape presents ongoing challenges for Pharmacovigilance systems. To help your team stay ahead, Oviya MedSafe offers comprehensive, up-to-date training that equips your staff with the latest industry knowledge and regulatory expectations.

As part of our consulting services, we assist in the early stages of setting up your Pharmacovigilance system, strategically planning for compliance and risk management. Our training programs cover essential areas such as safety reporting, signal detection, and regulatory submissions, ensuring your team is well-prepared to handle the complexities of Pharmacovigilance.

With a deep understanding of current industry trends and global regulatory requirements, we tailor our training to meet your organization's unique needs, enhancing the effectiveness of your Pharmacovigilance operations and ensuring long-term regulatory compliance.

A robust Pharmacovigilance Quality Management System (PV QMS) forms the backbone of compliant and effective Drug Safety operations. At Oviya MedSafe, we specialize in designing and maintaining PV QMS frameworks tailored to meet the unique needs of your organization while adhering to global regulatory standards. Our expertise includes developing quality policies, processes, and procedures to ensure seamless integration with your organization’s operations. We help establish clear accountability, manage risks effectively, and drive continuous quality improvement across all Pharmacovigilance activities. In addition to creating a strong foundation for compliance, we assist in maintaining your PV QMS by conducting periodic reviews and updates to reflect evolving regulatory requirements and industry best practices. Whether you are building a PV QMS from the ground up or optimizing an existing one, Oviya MedSafe ensures your systems remain robust, efficient, and audit-ready.

Pharmacovigilance regulations globally, including those from the EU and India, mandate the preparation and maintenance of a Pharmacovigilance System Master File (PSMF). This critical document provides a comprehensive overview of a company’s Pharmacovigilance system, supporting compliance with regulatory requirements across diverse jurisdictions.

The PSMF details key elements such as Pharmacovigilance procedures, safety databases, Quality Management Systems (QMS), and business continuity plans. Its preparation and upkeep require meticulous attention to regulatory standards, including Good Pharmacovigilance Practices (GVP) and region-specific requirements.

At Oviya MedSafe, we specialize in preparing and maintaining PSMFs that are compliant, audit-ready, and reflective of global and local regulatory expectations. Our expertise ensures that your PSMF aligns with the highest standards of Pharmacovigilance, enabling you to meet regulatory demands with confidence.

At Oviya MedSafe, we are leading the transformation of Pharmacovigilance (PV) through the integration of advanced technologies, including AI and machine learning. In addition to supporting pharmaceutical companies, we collaborate with technology companies developing PV solutions, offering valuable Subject Matter Expertise (SME) to enhance AI-driven tools for Drug Safety management. We help optimize automation in signal detection, adverse event reporting, and risk assessments, improving both efficiency and accuracy.

Our services also include PV Change Management, guiding clients through the migration from one PV system to another, ensuring smooth transitions while maintaining compliance and operational effectiveness. Whether with or without technology involvement, we support functional consulting during system upgrades or migrations.

By embracing these advancements, Oviya MedSafe ensures that both pharma companies and technology providers benefit from the latest innovations in PV, helping them stay ahead of regulatory demands and enhance Drug Safety practices.

At Oviya MedSafe, we offer strategic deployment of highly skilled contract staff to pharmaceutical companies, AI technology firms, and other organizations in need of specialized expertise in Pharmacovigilance and related fields. Our staff are deeply knowledgeable, and provide tailored staffing solutions to meet both short-term and long-term project needs.

We manage all aspects of recruitment, training, and payroll administration, allowing you to focus on core operations without the burden of handling individual contractors. Our staff seamlessly integrate into your teams and contribute to critical functions such as safety reporting, risk management, regulatory compliance, and AI technology integration.

By partnering with Oviya MedSafe, you gain flexible access to expertise at the right time, enabling you to scale your workforce efficiently while ensuring the highest standards of quality and compliance.