Pharmacovigilance Officer - Ireland
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- Our company employs approximately 9,500 people with a market cap in excess of €2 billion.
- Our company is a leading healthcare business with sales in excess of €300 million, over 800 employees and an ambition to be one of the leading players in the supply of products and services to the healthcare sector in Europe.
- Our company is focused on driving organic growth in its existing businesses and identifying new growth opportunities that strengthen and expand its product range, broaden its geographical reach and improve its business.
- Our company operates across three key divisions - Pharma, Medical Devices and Logistics:
Principal Duties and Responsibilities:
- 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
- Should we add bullet on spontaneous ADR eavaluation as you have points on the above ?
- 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.
- Respond to medical information queries
- Respond to queries form regulatory authorities
- Review product information, prepare Addendum to Clinical Overview as required
- Liaise with the Regulatory Department to ensure label updates arising from Pharmacovigilance activities are implemented in a timely fashion.
- 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.
- Optimise the use of resources at all times.
- Participate and assist in the training of Pharmacovigilance personnel.
- Provide Pharmacovigilance support and advice to relevant departments.
- Make recommendation relating to general improvements of the business.
- Attend external meetings/training courses to maintain/improve overall knowledge of Pharmacovigilance procedures, guidelines and directives.
- Complete any other duties as considered necessary by the Company.
- 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.
- Full-time, permanent role