Pharmacovigilance Systems Specialist
CPL
Dublin , Dublin West
Pharmacovigilance Systems Specialist – Dublin West – Permanent – 45K My client, a global pharmaceutical company based in Dublin West, are looking for PV Systems Specialist to manage the system-level functionality of PV databases. The Job: You will be liaising with PV systems vendors on issues relating to data extraction, systems functionality and user access as well as potential upgrades of those systems. You will be involved in delegation of PV systems-related tasks from the PV Systems Manager (PVSM), EU QPPV and the Group Executive on an ad hoc basis. You will be liaising with PV Quality Management and Compliance Manager (PV QMCM) to document deviations from SOPs relating to PV Systems and providing assistance with generation and implementation of any resulting CAPAs. You will review and advise on relevant local & global guidelines, policies, internal procedures and SOPs across company affiliate companies. You will be involved in database management of the safety database system with assistance from the vendor support team You will be managing users’ access with regards to safety database and ensuring adherence to number of licences acquired. You will be involved in database management of the MPD database system with assistance from the vendor support team and the company’s IT department including: - Project management of patches and upgrades to the MPD database system. - Project management of updates to the Medicinal Product Dictionary (MPD) and the Company Product Dictionary (CPD) including code lists and coding dictionaries. Your role will be coordination of triage, data entry, quality control, medical review and final submission of all product data into MPD with assistance from the Case Workflow Manager and the ICSR processing team. The Fit. On the technical side you will need: Life sciences/biological sciences graduate. Minimum 3 years’ experience in pharmacovigilance. Competent in database administration. Competent in team leadership. Competent in medical terminology. Strong enterprise application/IT skills. Excellent oral and written English communication. Detail oriented, solutions provider with the ability to multi-task and work with a high degree of accuracy. Highly organized and flexible. Above average computer skills. Decision making. Problem solving. Service orientation. Time Management and task prioritization. Process driven. Occasional travel may form part of the job. To apply: Are you the one? Apply now by clicking the Apply button, or email me for more information at Amina.Tutunova@cpl.ie. Not ready to apply, or have some questions first? Call me, Amina Tutunova, on (01) 6146161 to discuss in confidence! This job originally appeared on RecruitIreland.com.
2193 days ago