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Drug Safety Officer Case Management Ghent Belgium,  

Posted on : 08 May 2017

Project Description

Tracking Code 2015905 Job Description   Responsibilities:   Data handling of all adverse events and special situations according to appropriate SOP and WI’s Data entry and causality assessment adverse events into the PcV manager Ensure timely reporting to competent authorities and safety partners Coordination of Pregnancy Follow Ups Continuous updating of all relevant documents and Overviews (e.g. lists for literature search,...) ADR reconciliation with safety partners (co- distributors, manufacturers, …) ADR reconciliation with complaints and affiliates Reconciliation of medical enquiries with complaints and affiliates Provide input to Sr. PV Operations Officer on ICSR handling/ data entry/reporting for creation of training material On the job training, evaluation and coordination of PV colleagues on case handling and using the global safety database Coordinating quarterly checklist Handling of information and results of global literature search Coordinating Local literature search and literature searches for other purposes (e.g. PSUR, ACO) Ordering of articles and coordinating the translation of articles Coordinating ICSR collection from MLM service Managing the global pharmacovigilance mailbox Querying and eextracting data out of the global safety database Extraction of KPI for data entry data from the PcV manager     A life science degree is required A minimum of 1-2 years of experience in PV/Drug safety in case management/processing MedDRA experience Strong oral and written communication skills Ability to manage workload and meet strict deadlines Be able to work in a matrix environment whilst remaining organized at all times Fluent in English, other languages are an asset Proficient in MS Office applications (Excel, Word, Outlook). Knowledge of medical terminology Job Location Ghent, , Belgium Position Type Full-Time/Regular


Ghent Belgium

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