News
Paraxel are currently recruiting for Consultants in their Kilmainham Dublin office. The website link is https://jobs.parexel.com/job/dublin/regulatory-affairs-consultant/877/9246740.
CMC Consultant Overview:
A Consultant must have an understanding of the organization’s consulting models and methodologies, as well as, good knowledge of what services PC provides.
A consultant must have strong technical skills and may be developing specialist knowledge of a particular subject and/ or market.
A consultant ensures the timely performance of work within a project scope to the quality expectations of PC and the client. When serving as a Project Technical Lead, a Consultant assures the work of the entire team is delivered on time and that it meets client’s and PC’s quality expectations.
Qualifications:
-Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline, Advanced Degree Preferred
-Several years of experience in an industry-related environment
Skills required:
-Variation/Lifecycle Maintenance experience EU/RoW: Simple (Type I), complex variations (Type II) to EU markets in the CP and NP procedures, Renewals etc.
-Change Control assessment experience
-Capable of participating in discussion on regulatory strategies with a wide stakeholder network (QA, Brand Leads etc.) with support of an SME
-Proactive’ and ‘efficient working method
-Strict adherence to timelines (both internal and HA deadlines)
-Excellent interpersonal and intercultural communication skills, both written and verbal
-Client-focused approach to work (Quality)
-Results orientation
-Teamwork and collaboration skills
-Critical thinking and problem-solving skills
-Proficiency in local language and extensive working knowledge of the English language
Posted 25th Oct 2018
EirGen Pharma in Waterford (part of OPKO, Miami, US) are recruiting a number of Science graduates to join their Regulatory/Clinical Affairs team with immediate start. The Regulatory department has a structured training program for graduates delivered by both internal and external trainers with extensive experience of Global Regulatory Affairs. This is an exciting opportunity to join an expanding Regulatory Affairs department supporting EirGen's newly built R&D facility in the space of New Drug Development and niche Generic drug development in a variety of dosage forms, including Oral Solid Dose – immediate and modified release, soft capsules and liquid fill hard capsules and Fill/Finish for both small molecules and biologics. See job description for further information EirGen Reg Affairs Office positions_Aug 2018.
For anyone who wishes to apply they can send a copy of their CV to HR@Eirgen.com.
Posted 19th Oct 2018
PIER is organising a careers evening in RCSI College Hall for undergrads, interns and pharmacists interested in careers in the pharmaceutical industry.
The event will take place on Wednesday evening 7th November 2018. The formal part of the evening will run from 6.30pm-9.00pm with refreshments available from 6.00pm.
Attendees will be invited to rotate around nine focus areas (Commercial, Consulting, Manufacturing/Tech Services, Market Access, Medical, Drug Safety/Pharmacovigilance, Quality & Compliance, HPRA, Regulatory Affairs) where they can learn about some of the interesting careers in industry by chatting to pharmacists working in the particular area.
Email careerhub2@rcsi.ie to register.
For further information see, RCSI Careers Evening 7th Nov 2018.
PIER in collaboration with EIPG are organising a webinar on the topic of 'Integrated Quality Management Systems'. The presenter is John Jolley (PharmaConsult Global) and will be held on Monday 15th October at 4pm (GMT).
In his talk on the requirements of an Integrated Quality Management system, John will include the principles of applying quality risk management, the management of product and process deviations, CAPA and change control, audit management of inspections and the management of enterprise resource planning and supplier quality management.
Numbers are limited and are on a first come, first serve basis. Anyone applying to participate and then finding they are unable to do so must cancel their participation before the event.
For further information, see Integrated QMS webinar_15th Oct 2018.
PIER in collaboration with EIPG are organising a webinar on the topic of 'FMD Implementation- Insights from a National Medicines Verification Organisation'.
The deadline for the implementation of the Delegated Regulation on Safety Features is fast approaching and industrial pharmacists throughout the entire pharmaceutical regulatory and supply chain will be interacting closely with their NMVO in the coming months. This webinar will provide insights into how an NMVO operates and an understanding of the importance of collaboration between all players and their national MVO, as part of the European network, in order to ensure the success of this project. The presenter is PIER member Leonie Clarke, Project Manager IMVO. It will be held on Tuesday 25th September at 4pm GMT.
Numbers are limited and are on a first come, first serve basis. Anyone registering to attend and then finding they are unable to do so must cancel their participation before the event.
For further information, see FMD webinar_25th Sept 2018.
A recording of the recent EIPG/PIER webinar (FMD webinar_25th Sept 2018) hosted by Leonie Clarke (IMVO) on 'FMD Implemenation-Insights from a National Medicines Verification Organisation' is now available in the members area of the PIER website. A copy of the presentation slides is also posted. Access is via password which is posted in the members area of the PIER website.
PIER will be holding a careers information event in RCSI College Hall on Wednesday 7th November 2018 from 6.30pm.
The PSI recently notified over 1400 pharmacists of their selection for the 2018/19 ePortfolio Review. In early 2019, these pharmacists will be required to submit evidence of their continuing professional development to the IIOP via their ePortfolio.
Between September and December 2018, the IIOP will hold a series of evening and lunchtime face-to-face and webinar information events to support pharmacists selected for ePortfolio Review.
These events will include;
1. a focus on the requirements of the 2018/19 ePortfolio Review,
2. an explanation of the 2018/19 ePortfolio Review Standards,
3. the timelines for ePortfolio Review,
4. an introduction to the training support resources,
5. an opportunity to ask any questions regarding the 2018/19 ePortfolio Review.
Pharmacists who took part in last year’s ePortfolio Review consistently highlighted the IIOP information events as a key source of support in their preparation. They felt more confident in participating in ePortfolio Review and had a clear understanding of what the Standards were and how to access support if needed following attending an event.
The IIOP will hold 10 face-to-face information events (locations listed below) and 18 webinar events. Places for all events can be booked on the IIOP website (https://iiop.ie/events).
|
Date |
Venue Confirmed |
|
25-Sep-18 |
Rochestown Park Hotel, Cork |
|
25-Sep-18 |
Royal College of Surgeons in Ireland, Dublin |
|
9-Oct-18 |
Radisson Blu Hotel & Spa, Limerick |
|
10-Oct-18 |
Dublin West, Venue TBC |
|
23-Oct-18 |
Radisson Blu Hotel, Dublin Airport, Dublin |
|
24-Oct-18 |
Maldron Sandy Road, Galway |
|
13-Nov-18 |
Radisson Blu Hotel, Athlone |
|
20-Nov-18 |
Hotel Kilkenny, Kilkenny |
|
27-Nov-18 |
Clayton Hotel Leopardstown, Dublin |
|
4-Dec-18 |
Crowne Plaza, Dundalk, Louth |
The HPRA are currently recruiting for a Pharmaceutical Assessor, in the Pharmaceutical Assessment – Human Products Authorisation and Registration Unit. Would be an ideal position for a pharmacist with some industry experience.
Irish Medicines Verification Organisation (IMVO) are looking for an experienced quality professional for the role of Quality Manager. This will be a part-time (0.5 FTE) position, based in Dublin. For further information, please see the role profile IMVO Quality Manager (part-time).
To apply or to make an informal enquiry, please contact Leonie Clarke, IMVO Project Manager (email leonie.clarke@imvo.ie).
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)
Find out more about the PBF and the work they do 