What you need to know
We are seeking an experienced PV Officer for our highly successful client based in the Midlands.
The PV Officer is responsible for carrying out pharmacovigilance activities in accordance with Good Pharmacovigilance Practices and company Quality Management Systems for the DCC Vital group 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.
- 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.
- Previous experience in a similar role.
- Attention to detail.
- Ability to plan projects in order to meet deadlines.
- Ability to work as part of a team and independently.
- Strong IT literacy.
Apply for this job now or get in touch with Áine on 090 6490485
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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