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Case Processor

Introduction



Function

– 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.

Requirements

Degrees:

· 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