Our Pharmacovigilance department offers medical monitoring and expedited SUSAR reporting to the EudraVigilance database by certified Safety Officers.
Our Medical Monitor, a full-time, in-house Physician, qualified for medical monitoring according to regulatory requirements, works on behalf of you as a sponsor, either alone or in close collaboration with your medical representative.
Besides taking a full medical monitoring responsibility, the Medical Monitor, who is also the Director of the Pharmacovigilance unit, can assist in a broad range of services including medical review of SAEs and SUSARs (including assessment of causality and expectedness), safety management oversight and investigator support in case of safety issues in both investigational medicinal product (IMP) and medical device studies. 24/7 medical service can be provided if requested.
Other services provided by the Pharmacovigilance department include Data Monitoring Committee (DMC) handling (management, planning, documentation etc.) and coding of adverse events, medical and surgical history and prior and concomitant medications using the MedDRA dictionary or the ATC classification system, respectively, by our trained Medical Coders.
Cornelia Lif-Tiberg, MD, Director Pharmacovigilance