News
Recordati Ireland have a vacany for a Regulatory Affairs Manager. This role involves the regulatory management of Recordati Corporate products all over the world, in strict cooperation with the International Pharma Sales Team at Recordati Ireland and with the International Regulatory Affairs team at the HQ in Milan, Italy. Recordati Ireland is responsible for over 1000 marketing authorizations in over 100 Countries.
See job description Recordati Ireland Reg Affairs Manager role.
Posted 14th Dec 2018
Join PIER members and friends for Xmas Connect drinks gathering in The Lincoln, 19 Lincoln Place, Dublin. An area will be reserved.
Email membership@pier.ie to register by Wednesday 5th Dec 2018.
MSD Ballydine are currently recruiting for a Quality Specialist role which may be of interest to recently qualified pharmacists.
MSD Ballydine develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan.
For further information, see MSD Ballydine Quality Specialist role.
Posted 30th Nov 2018
IQVIA (formerly Quintiles) are recruting for a number of positions in their Dublin office (Eastpoint Business Park):
- Pharmacovigilance Specialist
- Medical Information & Safety Operations Specialist (Languages required- French, German, Spanish, Italian, Dutch)
- Pharmacovigilance Specialist (Regulatory Reporting)
If you have any questions about the above vacancies, please feel free to contact Lana Wills – Lana.Wills@quintiles.com.
Posted 19th Nov 2018
PIER members may be interested in this event 'Digital Health-The Skills of the Future' event being organised by Healthcare Businesswomen's Association in EY offices, Dublin on Thursday 22nd November 2018. Pharmacist and PIER career webinar presenter Michelle Cuddigan (EY) will be chairing the panel discussion.
For further information, see HBA Digital Health Skills of the Future event
MSD Ballydine are currently recruiting for a Technical Process Engineer position which may be of interest to pharmacists with an interest and some experience in a technical manufacturing role. MSD Ballydine develops and supplies the active ingredients and final formulated product for a range of innovative medicines at its manufacturing and R&D facilities. The plant, which has been operating in Tipperary for over 40 years, exports to over 25 countries around the world with primary markets being Europe, USA and Japan.
For further information, see MSD Ballydine Technical Process Engineer role.
Posted 15th Nov 2018
The PIER 2018 Autumn CPD meeting & AGM will take place on Sat 1st Dec 2018 in Clayton Liffey Valley, Dublin (9.30pm-1pm). The theme of the CPD meeting is 'Insights into Rare Diseases'. The agenda is as follows:
- Aoife Coughlan (Genomics Medicine Ireland) 'Solving the diagnostic odyssey of rare diseases in Ireland'
- Geraldine O'Dea (HPRA) 'An overview of the work of the Committee for Orphan Medicinal Products'
- Linda Vittone (Vertex) ’From bench to bedside, the development of orphan medicines’.
The PIER AGM will take place after the CPD meeting.
To register, email education@pier.ie before Thursday 29th November 2018.
On Thursday November 29th 2018, the IIOP will host a pharmacy practice research event aimed at pharmacists currently involved in the area, and at those who would like to become involved. It is hoped that that this can help pharmacists who have identified research as an area for development through their CCSAT.
Registration is via the IIOP website.
For further information see, IIOP Pharmacy Practice Research Event Agenda and IIOP Pharmacy Practice Research Event Flyer
PIER in collaboration with EIPG are organising a webinar on the topic of 'Data Integrity' on Tues 11th December 2018 at 4pm GMT. The speaker is Dr Alessandro Regola who has extensive experience in GMP and quality systems. The session will be chaired by Dr Piero Iamartino, EIPG Vice-President, Technical and Professional Development.
Overview of Webinar: The presentation will cover the issue related to the integrity of GMP relevant data that the pharmaceutical industry has been struggling with for the past 5-7 years mainly due to violations recorded during Authority inspections to pharmaceutical (both API and drug product) manufacturing facilities. Most common and frequent compliance issues related to paper, IT or hybrid (paper+ IT) systems will be discussed. A recommended risk assessment and remediation approach will be presented, including the classification of affected system based on risk for the quality of the product and the patient health, the evaluation of the gaps and the prioritisation of corrective actions.
For further details on the webinar and how to register, see EIPG PIER webinar on Data Integrity_11th Dec 2018.
Useful Links
- Academy of Pharmaceutical Sciences (APS)
- European Industrial Pharmacist Group (EIPG)
- European Industrial Pharmacists Group Newsletter
- European Medicines Agency (EMA)
- Health Products Regulatory Authority (HPRA)
- Irish Institute of Pharmacy (IIOP)
- Irish Medical Device Association (IMDA)
- Irish Pharmaceutical Healthcare Assocation (IPHA)
- Pharmaceutical Managers Institute (PMI)
- Pharmachemical Ireland
- The Pharmaceutical Society of Ireland (PSI)
- UK & Ireland Controlled Release Society (UKICRS)
- The Organisation for Professionals in Regulatory Affairs (TOPRA)
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