Isioma Obazee

Case Specialist @ProductLife Group

Cambridge, GB

Entry of pharmacovigilance safety reports (spontaneous, authority, literature).• Assessment of Seriousness, Expectedness/Listedness of Adverse Events• SAE Reconciliations, Audit and CAPA management.• Client submissions and administrative tasks relating to safety reports.• PV activities for allocated studies, including project management, and set-up of projects in line with contracts.• Quality control of safety reports, including AEs and SAEs from clinical trials, spontaneous, Health Authority and literature reports.• Eudravigilance registration and all other required activities on behalf of the client.• Drafting, reviewing, and updating SOP/WPDs and applicable quality documents• Submission of safety reports to Competent Authorities• Key contact for client-specific projects• Transmission of reports to partners.• Medical evaluation of safety reports• Follow-up requests.Skills: GVP · ICH · Case processing · Cosmetovigilance · Medical device vigilance. Medical writing. Quality Assurance · Teamwork · Team Leadership · Medical Terminology · SafetyEasy and ARGUS database · Advanced MedDra Coding · CIOMS · MED WATCH · TGA · E2B · Microsoft Excel. Sharepoint.Pharmacovigilance

University of Benin

Doctor of Pharmacy - PharmD, Pharmacy

University of York

Master of Public Health - MPH, Public Health

Institute of Strategic Management of Nigeria

Associate Member, Strategic Management

University of Benin

Bachelor of Pharmacy - BPharm, Pharmacy