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Snr QA Specialist
Dublin South
QA Specialist
Dublin West
Head of Quality
Dublin West
Market Access Manager
Dublin City Centre
Microbiologist
Kilkenny
Surgical Sales Specialist
Republic of Ireland
Biostatistician
Dublin City Centre
QP Biologics
Dublin
QA Manager
Meath
Senior Chemist
Dublin North
R&D Engineer
Galway
QA Manager
Dublin West
QA Manager Biologics
Dublin West
Program Manager
Westmeath
Snr Process Engineer
Dublin North
Qualified Person
Dublin West
Consultant
Brian Christensen
Life Science

+353 (0)1 685 47 47
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Pharmacovigilance Career Profile

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