Job Title.	Location	Salary	Actions
Vigilance Assessor Reporting to the Director of Human Products Monitoring the role of the Vigilance Assessor is to provide post marketing evaluation and regulation of the benefits and risks of medicinal products in Ireland and the European Union and to provide technical support to the Director of Human Products Monitoring in order to facilitate the effective safety monitoring of medicinal products. A degree in Pharmacy or a PhD with 3 years research experience is essential for this role. Role/Responsibilities: o Signal detection activities using available databases and with integration of quantitative ... Location: Dublin, Vigilance Assessor	Dublin	Not Disclosed

Pharmacovigilance Officer

The Pharmacovigilance Officer (PVO) is responsible for the monitoring and reporting of adverse effects from company pharmaceutical products on the market. This information is supplied to the PVO by medical representatives, patients, doctors and other healthcare professionals in the field. It is the responsibility of the PVO to ensure that this data is suitably recorded, analysed and accurately processed while building strong collaborative relationships with medical affairs, commercial affairs and corporate (Global) pharmacovigilance (PV) functions. The PVO informed opinions will help the company maximise product safety and performance.

Typically the Pharmacovigilance Officer holds a degree in Pharmacology or a related life sciences field and about 3-5 years experience in clinical trials, regulatory or another medical affairs area. Typically graduates can secure entry-level PV associate positions in Contract Research Organization (CRO's) however it is difficult to secure entry level PV positions in pharmaceutical companies in Ireland.

Key Activities of the PVO

• Periodic Safety Update Reports (PSUR)
• Write and review Serious Adverse Effects (SAE) narratives and Council for International Organizations of Medical Sciences (CIOMS) forms for the pharmacovigilance department
• Signal detection (detection of early warning signs)
• Risk minimisation
• Safety exchange agreement
• To perform training for other departments as appropriate
• Clinical trial activities