Geraldine O'Brien Email and Phone Number

Employed by the Alpha-1 Foundation a respiratory research charity with responsible for:•Maintaining Alpha-1 screening database. •Preparing reports, talks and posters for scientific meetings. •Obtaining informed consent from patients and preparing patient information leaflets.•Performing diagnostic procedures and assays, analysing data and ensuring up to date records and reports on Alpha-1 patients.

As a biomedical scientist I was responsible for:• The collection and processing of patient samples and the reporting of results according to agreed timelines.• Adherence to company standard operation procedures.• Inventory and correct preparation of reagents.• Maintenance and calibration of laboratory equipment.• Prepare for internal and external audits.

As pharmacovigilance lead I worked on several oncology and cardiac studies. This involved the collection of safety data from clinical trials and post marketing studies. My duties included: • The review, assessment and processing of patient safety data.• Preparation and distribution of reports to pharmaceutical company, regulatory authorities and/or ethics committees.• Management of study projects and teams to ensure all deadlines are met and finance and quality control reports… Show more As pharmacovigilance lead I worked on several oncology and cardiac studies. This involved the collection of safety data from clinical trials and post marketing studies. My duties included: • The review, assessment and processing of patient safety data.• Preparation and distribution of reports to pharmaceutical company, regulatory authorities and/or ethics committees.• Management of study projects and teams to ensure all deadlines are met and finance and quality control reports are submitted to sponsor companies.• Presentation of the importance of correct safety data capture to large groups of colleagues, doctors and sponsors at clinical trial start up meetings• An in-depth knowledge of the study drug and therapeutic area along with the ability to organise.• Excellent knowledge and understanding in good clinical practice in line with ICH-GCP, WHO, EU, US and company guidelines. Show less