Our primary objective is to ensure the ongoing safety and efficacy of our medicines during their life cycle.
Our pharmacovigilance system enables us to promptly gather accurate safety data for all the medicines we represent across every market we operate. It adheres to Good Pharmacovigilance Practices (GVP), European and local regulations, as well as the stringent safety standards established by our international partners. Our system undergoes regular inspections by local authorities and our partners, and it is certified by the international ISO 9001 Quality Management standard.- We handle adverse event reports for all our medicines.
- We maintain communication with local authorities regarding safety issues, with a Local Pharmacovigilance Responsible available 24/7.
- We implement risk mitigation measures in compliance with local regulatory requirements.
- We oversee and coordinate pharmacovigilance activities in all the countries where we operate (both EU and non-EU).
- We enact Emergency Management Plans to ensure Business Continuity (also known as Business Continuity Plans).
At GENESIS Pharma, pharmacovigilance is a shared responsibility. Therefore, we provide systematic training to all our employees and external partners to promptly and effectively identify potential safety issues.
Whether you are a healthcare professional, patient, or in any other role, reporting a suspected adverse drug reaction actively contributes to the continuous monitoring of the safety and quality of our medicinal products.
If you would like to report a suspected adverse reaction related to our drugs, please refer to the contact details provided below. Bear in mind that all information gathered during the reporting of an adverse reaction is kept confidential and anonymized, ensuring the anonymity of both the reporter and the patient.
Hematology, Oncology, Immunology and Inflammatory diseases, Rare diseases
E: pharmacovigilance@genesispharma.com
Central Nervous System and Rheumatology diseases
E: pharmacovigilance-CS@genesispharma.com
POST: GENESIS Pharma S.A., (att: Pharmacovigilance Department), 270 Kifissias Avenue, Halandri, 152 32 Athens