Our Client, One of the leading health care business in Britain and Ireland based in Roscommon is currently sourcing for Pharmacovigilance Officer. The PV Officer is responsible for carrying out pharmacovigilance activities in accordance with Good Pharmacovigilance Practices and company Quality Management Systems for the company and clients where applicable.
• Screen worldwide (local) scientific literature on a weekly basis and evaluate relevant information for inputting on to an internal database.
• Evaluate adverse event reports received directly from regulatory authorities and input relevant reports onto an internal database
• Process safety data arising from all source as per SOPs
• Report safety data using EudraVigilance
• Input into extended EudraVigilance Medicinal Product Dictionary
• Prepare and participate in regular signal detection meetings
• Prepare and ensure submission of PSURs and Risk Management Plans in a timely manner.
• Update Pharmacovigilance System Master File as required.
• Ensure identified safety variations are planned, tracked and sent as per set timelines in accordance with the legislation.
• Prepare weekly reports for the Regulatory Manager and QPPV.
• Ensure compliance with Volume 9A of The Rules Governing Medicinal Products in the EU and GVP modules, Reg 1235/2010, Reg 520/2012 and directive 2010/84/EU as applicable, and also the company procedures
• Identify and implement practices to improve the Pharmacovigilance system including review of SOPs as required.
• Attend external meetings/training courses to maintain/improve overall knowledge of Pharmacovigilance procedures, guidelines and directives.
• Third Level qualification in a scientific discipline
• The role demands a well-organised approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing.
• Reliability, IT literacy and the ability to plan and complete projects to set timelines is essential.
If you would like further Information you can contact the recruiter directly:
Jannet Diana | Tel: +353 (0) 1 507 9255