JOB DETAILS
Louth, Meath, Dublin North
Pharmacologist, Quality Assurance Analyst
JOB DESCRIPTION
Drug Safety Officer
Location: Dublin North City, Louth, Meath
Salary: 35 000K - 38 000K
Drug Safety 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. YOUR CV WILL BE TREATED WITH THE STRICTEST CONFIDENCE Specialists in
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