SAFETY OFFICER / MUB
2013-12-12
Our client, medical device company with focus on cardiology is looking for Safety Officer.
Responsibility: Safety/Monitoring for Adverse Events CRA - Guarding patients’ safety in clinical trials and conducting adverse event reviews and handling according to regulatory requirements (EC and Other Regulatory Bodies) and sponsor’s ethical responsibility.
Interact with CEC for the purposes of safety data collection, data reconciliation, and providing source documents for the CEC reviews
Provide additional information and updates to the complaint handling group regarding patients’ outcomes and associated/related complaints.
Advise research coordinators and CRAs to properly report adverse events and provide the proper supporting documentation for SAEs (serious adverse events).
Supporting CRAs and sites AE reporting training, and cross function training and expertise regarding complaints handling
Required experience
A MD degree is strongly desired, if not possible minimum of bachelor’s degree in a related biological or life science discipline, or a nursing diploma/associates level degree is required.
3-7 years of experience in clinical research, with at least 2 years Safety/AE handling within the medical device industry.
Requires knowledge of global regulations and guidelines for Adverse Events AE/UADE reporting, conducting Clinical Research and ICH/GCP (Good Clinical practices).
Understanding of medical device regulatory requirements and documents, device accountability and clinical safety medical device regulatory documents/adverse events reporting and handling.
Knowledge of interventional coronary or peripheral products such as stents, open or minimally invasive cardiac surgery or other class II devices.
Experience with remote data capture strongly preferred.
Ability to communicate and relate well with key opinion leaders and clinical personnel
In case of interest please send your CV to bukacova@hays.cz.
