On behalf of our client, we are currently recruiting for a Vigilance Assessor, Human Products Monitoring. This is a 3 year contract role. The role is hybrid with 3 days in Dublin office and 2 days remote.
ROLE SUMMARY
The Vigilance Assessor will work as part of a dynamic multi-disciplinary team within the Human Products Monitoring (HPM) Department. They will be responsible for monitoring the benefit-risk profile and for assessing risk management planning activities of medicinal products in Ireland and in the European Union in the post-marketing setting.
The Vigilance Assessor will be closely involved contributing to and leading safety assessments conducted both nationally and as part of the European network and will actively support the company’s contribution to the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee.
The key activities of the role will involve:
-Scientific evaluation of cumulative and emerging data on the risks of medicinal products from various post marketing sources including clinical studies, pharmacovigilance databases and scientific literature to facilitate the timely detection and assessment of any safety concerns.
-Consideration of the impact of such evaluations on proactive risk management planning for the medicinal product including the need for, design and evaluation of postauthorisation safety studies.
-Regulatory communication of such risks to healthcare professionals and patients in order to ensure the safe and rational use of medicines on the Irish market.
The position may be suitable for an individual with a pharmacy/life sciences background with relevant clinical experience together with experience in conducting literature reviews, data analysis and critical appraisal to support clinical decision-making. Candidates should have a demonstrated ability for technical scientific report writing. Preference will be given to candidates with research experience, in particular in the area of pharmacoepidemiology or similar discipline.
QUALIFICATIONS AND EXPERIENCE
o To be considered for this post, candidates must:
o Have a degree in pharmacy or other closely related scientific discipline.
o Have at least 2 years relevant experience (acquired after the qualification required above)
o Have a relevant post graduate qualification, preferably in the area of pharmacoepidemiology, medical statistics or other closely related scientific discipline.
o Have experience in conducting literature reviews, data analysis and critical appraisal and have demonstrated an ability for technical scientific report writing including as part of research conducted in the academic, clinical or industrial field of medicine.
o Have experience in the use of medicinal products in the clinical setting with a preference given to candidates who have experience in direct interaction with healthcare professionals and patients as part of provision of care or support
o Have an understanding of the principles of pharmacovigilance and risk management planning for medicinal products
o Be self-directed and have demonstrated an ability to use initiative and work independently
o Have excellent interpersonal skills
o Be of good character
o In addition to this the ideal candidate will also have one or more of the following; o Experience in working in the field of pharmacoepidemiology and/ or pharmacoepidemiological research
o Have experience of pharmacovigilance and risk management planning for medicinal products
For full details contact Linda at +353 1 2784701 or email your CV to [email protected]
Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
