PHARMACOVIGILANCE
At TOLLEON, we provide comprehensive CRO services, and through our specialized partners, we implement global and European Pharmacovigilance Regulations for Marketing Authorization Holders (MAHs) of pharmaceutical products within and outside the EU.
All pharmaceutical products in the European Union undergo strict quality, efficacy, and safety evaluations before approval, and post-market surveillance continues to ensure the detection and assessment of any factors that may affect drug safety. Pharmacovigilance is the science and process of monitoring drug safety, taking measures to reduce risks and maximize benefits. As a core public health function, it is handled with seriousness, responsibility, and professionalism by the Pharmacovigilance Department of TOLLEON.
Our responsibilities include:
- Collecting and managing safety data on pharmaceuticals.
- Analyzing data to detect new or changing safety concerns.
- Assessing data and making recommendations for safety measures.
- Implementing proactive risk management to minimize potential risks associated with drug use.
- Planning actions to protect public health (Regulatory Procedures/Actions).
- Organizing communication and information dissemination to stakeholders and the public.
- Reviewing and evaluating the effectiveness of actions and key procedures.
- Preparing and monitoring the implementation of a system for preventing, detecting, and assessing adverse drug reactions, including medication errors and overdoses, and reporting them to Marketing Authorization Holders or Regulatory Authorities.
- Strictly adhering to Good Pharmacovigilance Practices (GVP) Guidelines, as defined and updated by the European Medicines Agency (EMA).
- Provision of Responsible Person for Clinical Trial Pharmacovigilance (PR)
- Eudravigilance registration
- Assessment and medical review of serious adverse events
- SUSAR reporting to Eudravigilance, regulatory authorities, and regional investigators
- Ongoing risk/benefit evaluation of IMP
- Preparation and updates of Clinical Safety Reports (PSURs)
- Participation in Clinical Study Reports
- Preparation and implementation of Pharmacovigilance System (SOPs & PSMF)
- Collection, processing, and evaluation of adverse events
- Incident and potential incident management and reporting
- Risk Management System (RMS)
- Pharmacovigilance training
- Audits and Inspections in Pharmacovigilance
- Clinical Safety
- Adherence to a clear and defined traceability procedure
- Establishment of documented procedures with a practical and functional approach for the timely execution of product withdrawal, replacement, or recall, either by regulatory requirement or company decision due to serious safety concerns, mislabeling, or poor product quality.
Each Project Team is staffed with Safety Officers, Medical Advisors, and Session Assistants.
- EUQPPV / DEPUTY EUQPPV / LOCAL QPPV.
- 24-hour availability of EE/QPPV and DEPUTY EUQPPV.
- Scientific supervision of global and local scientific literature.
We guarantee high-quality services, excellent teamwork, strict adherence to agreed timelines, and the ability to expand our services to various European countries through our authorized partners, facilitating the growth and expansion of our client base.