Pharmacovigilance Officer

An exciting opportunity has arisen in a start up organisation based within Ireland in an emerging global pharmaceutical company.

Role Highlights:

• Receive and undertake case-processing of suspected adverse drug reaction (ADR) reports and ensuring timely reporting to UK regulatory authority.
• Follow-up and request further information from healthcare professionals on all notified adverse experiences.
• Review, track and submit non-UK ADR  reports to the appropriate regulatory authorities
• Create CIOMS-1 form for all initial reports of serious and non-serious ADRs reported globally from healthcare professionals, consumers, literature sources
• Scrutinise Anonymised Single Patients Prints (ASPPs) upon receipt from MHRA
• Remain fully informed of current developments within the pharmaceutical field relating to drug safety assessment, ADR reporting and pharmacovigilance, including regulatory issues  / changes
• Review literature reports concerning licensed products and scrutinize for serious adverse events occurring in the UK
• Prepare Periodic Safety Update Reports (PSURs)

The post holder should have 1-2 years’ experience in monitoring adverse drug reaction reports.  A thorough understanding of computerised databases and keyboard skills is essential, as is a good understanding of clinical practice.  This latter aspect must be gained either in a hospital or pharmaceutical industry environment.  Good inter-personal skills are essential. 

Must be educated to degree level in life / information sciences.  A postgraduate qualification in a field related to pharmacovigilance would be preferable; if not obtained, a further 2 years experience in a hospital or pharmaceutical industry would be desirable.

If you are interested in this position please apply online or contact Shane Brown on 01 6321865.