Human Pharmacovigilance Services
At OC Vigilance, we specialize in providing comprehensive pharmacovigilance solutions to ensure the safety and efficacy of medicinal products throughout their entire lifecycle. Our team of experts is dedicated to monitoring, evaluating, and managing adverse reactions associated with the use of human medicines, as well as any other safety-related activities, all while complying with the highest regulatory standards worldwide.
Our company can offer you all possible solutions to comply with the current pharmacovigilance regulations.
Our services include
- Implementation of a Pharmacovigilance System and Development of Standard Operating Procedures and Pharmacovigilance System Master File
We assist clients in implementing pharmacovigilance systems if they do not already have one, and in drafting the necessary standard operating procedures (SOPs) and the pharmacovigilance system master file (PSMF). We also provide support for updating and/or reviewing these documents.
- Acting as Qualified Person for Pharmacovigilance (QPPV)
We offer a comprehensive service acting as Pharmacovigilance Responsible Person at the European and Spanish levels and/or as a deputy, ensuring proper pharmacovigilance training, 24/7 availability, and guaranteeing correct performance of the activities overseen by the Responsible Person.
- Adverse Drug Reaction Management
We collect and analyze reports of adverse drug reactions from healthcare professionals, patients, scientific literature, and other sources, ensuring a rapid and precise response. Our team has expertise in using various commercial pharmacovigilance databases and applications for reporting adverse reactions to health authorities. - Pharmacovigilance Literature Search Service
We provide a specialized literature search service in pharmacovigilance, conducting a thorough and systematic investigation of relevant scientific literature. Our approach focuses on identifying and gathering critical information on drug safety, ensuring that our clients have accurate and updated data for decision-making. We use recognized databases, both globally and locally, applying rigorous criteria to ensure the quality and relevance of results, thus facilitating comprehensive and effective analysis of available information.
- Post-Marketing Safety Surveillance
We offer continuous monitoring of the safety profile of human medicinal products after they on the market to identify any potential risks and protect public health. We provide support for planning and preparing signal detection reports, as well as validating these reports and notifying the competent authorities. - Pharmacovigilance Audits
We conduct internal and external audits, ensuring a risk-based approach to confirm that pharmacovigilance processes are efficiently carried out, identifying areas for improvement and optimization.
- Pharmacovigilance Consulting
We offer personalized pharmacovigilance consulting services, assisting clients in resolving any doubts or challenges that may arise in the performance of their pharmacovigilance activities. We provide an approach tailored to their specific resources and needs, ensuring rigorous compliance with current regulations at all times. - Medical Advisory Services
Our medically qualified professionals provide support to our clients in any pharmacovigilance activities and/or medical inquiries. - Risk Management Plans (RMP) Development
We design and develop strategic risk management plans specific to each product, with the goal of mitigating potential risks and enhancing patient safety.
- Planning and Preparation of Periodic Safety Reports (PSUR)
We comprehensively manage the planning and preparation of PSURs according to the client’s portfolio and in compliance with applicable legislation and the European Union reference date list (EURD list). We prepare PSURs and submit them through the EMA’s PSUR repository.
- Post-authorization studies or patient programs
We provide full pharmacovigilance management support for post-authorization studies (EPA) and patient programs, ensuring compliance with regulatory requirements and the ongoing safety of treatments. Our team is responsible for the collection, analysis and reporting of safety data, helping to identify risks and trends in long-term drug use in real-world settings.
- Training and Education
We offer pharmacovigilance training programs for internal teams, healthcare professionals, and distributors, ensuring everyone is aligned with industry good practices.
- Communication with Health Authorities and Use of Pharmacovigilance Applications
We support registration on various applications needed for communications with health authorities and provide support in the use of each one (EV, EVDAS, PSUR repository, etc.).