QPPV – Veterinary
Our client a leading pharmaceutical manufacturer is recruiting for a Qualified Person for Pharmacovigilance. This role is based in Galway and is commutable from Westmeath, Tipperary and Clare. This is an opportunity to be part of a dynamic team within the Vet Regulatory Affairs function. We are looking for individuals who will support and drive the company’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
To act as the qualified person for pharmacovigilance (QPPV) for veterinary products.
- Maintaining pharmacovigilance system
- Conducting continuous overall pharmacovigilance evaluation during the post authorisation period of products
- Managing of the provision to the NCAs or the Agency of any other information relevant to the evaluation of the benefits and risks of a VMP
- Managing the Logging, investigating and reporting of Pharmacovigilance complaints received
- Managing the Preparation of Periodic Safety Update Reports for submission to Regulatory authorities in relation to national, MRP, DCP and centrally approved Marketing Authorisations
- Managing the submission of expedited reports when necessary
- Managing the maintenance of Pharmacovigilance systems (CRF’s PSUR data base, Line Listings)
- Collation of Pharmacovigilance data received from sub licensees
- Provision of Pharmacovigilance data to sub licensees
- Handling of requests for information from competent authorities,
- Handling of urgent safety restrictions and Submission of safety variations
- Remain informed with current pharmacovigilance requirements.
- Reviewing pharmacovigilance sections in Contracts and Agreements with third parties
- Identifying training needs for pharmacovigilance and implementing appropriate training plan.
- Oversight of quality control and assurance procedures within the pharmacovigilance system
- Oversight of SOPs within the pharmacovigilance system
- Oversight of compliance data in relation to the quality, completeness and timelines for expedited reporting and submission of PSURs within the pharmacovigilance system
- Oversight of pharmacovigilance audit reports
- Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands are key communication skills.
- Ability to build relationships and collaborate with others is vital.
- A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
- Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPIs to monitor the performance
- Positive and proactive person who is energised by having great responsibility
- Practical, action-orientated approach to managing priorities and teams.
- Strong computer skills in MS Office
The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
- Scientific qualification and background preferably B.Sc. or equivalent.
- Minimum 5 years in a FDA/CVM regulatory/R&D environment preferably with experience of pharmacovigilance. Knowledge of EU pharmacovigilance would be an advantage.
- Experience in busy problem solving environment with the ability to work to tight deadlines and on one’s own initiative.
- Detailed technical knowledge of products and processes.
- Strong Customer Service focus both internally and externally
- Good command of technical English (both written and spoken)
- Ability to work on multiple projects simultaneously.
- Communication skills with external and internal customers.
For further information on this QPPV role in Galway please contact Clara Burke on 086 8168273/ firstname.lastname@example.org
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