– Structured entry of serious and non-serious adverse events onto the project’s global PV safety database according to the project’s User Manual.
– Extraction of relevant information from routine source documents and/or information coming from the project’s affiliates via the Argus LAM or from E2B messages.
– Preliminary evaluation and assessment of case reports for seriousness, global listedness and causality of all serious and non-serious adverse events.
– Accurate and timely AE/SAE data entry taking into account the automated case prioritization by the project’s global PV database Argus and timely processing of Argus action items considering the system-generated due dates for completion.
– Creation of comprehensive case descriptions (narratives) in English language extracting relevant PV information from routine source documents.
– Checking of incoming PV information for consistency and completeness.
– Requisition of clarifications and additional PV information from the project’s affiliates and/or subcontractors within set timelines, as detailed in the project’s global SOPs.
– Verification of the accuracy of MedDRA and WHO-DD coding of reported adverse events, concomitant drugs.
· 1. Bachelor of Science in Biological Sciences
· 2. Bachelor in Allied Health
· 3. BSc Public Health (Hons)
· 4. BSc Human Nutrition (Hons)
· 5. Bachelor in Public Health
· 6. Bachelor in Pre-Medicine
· 7. Nursing Degree
· 8. Pharmacist
Experience in the execution of certain tasks : 0 to 2 years in case processing/ Pharmacovigilance.
IT skills (in details with required levels): Basic Computer skills