Job Title.	Location	Salary	Actions
GCP/Pharmacovigilance Inspector Our client is regulatory authority who are based in Dublin. They are seeking a GCP/ Pharmacovigilance Inspector to join an established team on a 2 year contract. Reporting to the GCP/Pharmacovigilance Inspection Manager, the role of an Inspector is to evaluate the compliance of sites inspected, both in Ireland and internationally, with the requirements of National legislation (in Ireland), European community directives, regulations and guidance. These include: Hospitals, Clinics, healthcare centres, clinical research facilities, sponsor organisations, CROs, C... Location: Dublin, GCP/Pharmacovigilance Inspector	Dublin	Not Disclosed
Director, Pharmacovigilance Quality & Compliance (GVP) Our client is a leading Global Biopharmaceutical organisation who play a crucial role in developing life-saving therapies. They are seeking a Pharmacovigilance Compliance Director who will join their Global R&D Quality and Compliance team. As a member of the global PV management team you will provide leadership in setting the strategic direction of Quality and Compliance PV activities. This role is suited to candidates who possess strong leadership skills and strategic thinking. Utilizing expert Good Pharmacovigilance (GVP) and Good Clinical Practice (GCP) knowledge. The su... Location: Dublin, Director, Pharmacovigilance Quality & Compliance (GVP)	Dublin	Not Disclosed

Job Title	Location	Salary	Actions
Regulatory Scientific Communications Associate	Cork	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