Pharmacovigilance Data & Systems Internship M/F

Les Ulis (France)
Student / Recent Graduate

The Job

Title: Pharmacovigilance Data & Systems Internship M/F Company: Ipsen Innovation (SAS) Job Description: #IpsenTraineeSquad Purpose of the Position Within the Global Patient Safety (GPS) Database System Support team, the Safety Database & Reporting Trainee will participate to the development, maintenance, validation of the Global Safety Database and associated systems. In this role, he/she will work with the Safety Database & Reporting Manager and the Safety Database & Reporting Coordinator to: Maintain the global safety system compliant with the pharmacovigilance (PV) regulations, with the Ipsen computerized system validation procedures and the GPS team's requirements. Generate safety database outputs (reports, listings, data extractions) using Ipsen Analytic Reporting tools interfaced with the safety database and support the development of new ad hoc and standard validated reports based on GPS and GPS stakeholders' requirements. Main Responsibilities and Tasks PV Systems / Tools Evolution- Project management Provide day-to-day support to Safety database and systems users in collaboration with IT support team Participate to the validation of the system as per Computerized System Validation methodology Maintain the Safety database reference data and dictionaries according to Ipsen global data referential Support the team for the maintenance of automatic distribution rules in the safety database Participate to the implementation of the new PV database Support the writing of validation test scripts Validate the data migration program by comparing data between source system and target system Participate to the update of the GPS quality documents (training material, work instructions user manuals) impacted by the change of system Analytical Reporting Maintain the list and schedule of recurrent reports, generate, and send the outputs as per the schedule Monitor and assign new reports requested through the Database Output Request process, respond to requests using standard reports Provide support to the Safety Database & Reporting Manager in the development of ad hoc / standard validated reports. Experience / Qualifications Degree in Sciences or Student in Pharmacy or student engineer, with an interest in pharmacovigilance Computer Sciences knowledge/understanding Having strong interest in data, data analysis, computerized system management project management Proficient user of modern IT and Office suite (Excel, SharePoint, Power BI) Fluent in written and verbal English Key Required Technical Competencies Volunteer, Curious, collaborative mindset Structured, systematic, and detail-oriented Analytical skills and scientific understanding Wish to work in an international environment #IpsenTraineeSquad Dans le cadre de ses recrutements IPSEN s'engage au respect de l'égalité de traitement des candidats, indépendamment du sexe, de l'âge, de l'orientation sexuelle, de l'origine ethnique, de la couleur de la peau, de la nationalité, du handicap ou de l'appartenance à un syndicat.
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