Pharmacist Pharma Ireland Job at DCC VITAL – in Kilcoole, County Wicklow
Company: DCC Vital – Fannin Ltd
Salary: Not Disclosed
Kilcoole, IE Leopardstown, IE, Dublin 18
Contract Type: Permanent
Date Posted: 31-Mar-2021
Our Pharma Ireland business includes Medisource and Fannin Pharma. Medisource are leaders in the sourcing and supply of exempt medicinal products for supply within Ireland and internationally. Fannin Pharma delivers sales, marketing & distribution services across hospitals, primary & community care. Our licensed portfolio of leading partner brands and generics comprises of a wide range of injectables, oral & solid dose medicines.
Job title: Pharmacist – Pharma Ireland
Location: Medisource – Kilcoole, Co. Wicklow & Fannin House – Leopardstown, Dublin 18 (60:40)
Reporting to: Group Pharmacist
Liaises with: Medisource and Fannin Quality Teams
Medisource and Fannin Management Teams
3rd Parties including Regulatory Bodies, 3rd Party Service Providers, Suppliers & Customers
The Pharmacist is responsible for supporting the management of Medical activities required for sourcing, marketing and distribution of pharmaceuticals across the Pharma Ireland business. The role is also responsible for supporting compliance with Good Distribution and Manufacturing Practices for the Pharma Ireland Wholesale Distribution (WDA) and Manufacturers Importers Authorisations (MIA). The Pharmacist will act as Deputy Responsible Person and will support the Qualified Person for the authorisations where applicable.
Principal Duties and Responsibilities:
To support the medical activities of the Pharma Ireland business including medical information and pharmacovigilance for medicinal products including the following:
Act as pharmacovigilance point of contact, liaising with customers, Marketing Authorisations Holders (MAHs), suppliers and the HPRA as required, documenting and following up to agreed satisfactory close out on all quality defect/ADR reports received
To support outsourced pharmacovigilance service provider for Pharma Ireland Marketing Authorisations
Liaising with MAHs and manufacturers in relation to requests for SPCs, technical/regulatory queries etc.
Advising customers on technical product specific queries.
To support the business in sourcing medicines and distribution partners including:
To have daily input into Medisource sourcing requests to meet patient specific needs based on the clinical nature of the product requested and the alternatives in the market
To work with the Medisource team in relation to export and market access opportunities
To classify products into appropriate product groups and assigning Taric codes to products
To support the Pharma Development Team in the identification and development of new supplier and product opportunities.
To act as Deputy Responsible Person (RP) for Medisource Limited WDA.
To support the Qualified Person (QP) for Medisource Limited and Fannin Limited MIAs.
To support the Good Manufacturing Practice (GMP) compliance requirements of the Pharma Ireland businesses to satisfy Manufacturer Importers Authorisations (MIAs) including:
To train in Good Manufacturing Practice requirements and to work with QPs to maintain the Pharma Ireland MIAs as applicable.
To support development and maintenance of GMP related standard operating procedures and documents and activities
To support MAH compliance requirements including:
MA Product Quality & Compliance Review processes
MA supplier qualification & maintenance processes
MA stability programme.
To support the Pharma Ireland Quality Management Systems including issues & actions management (Complaints, recalls, Non-conformances and related CAPAs), risk management, audits, document management and validation/calibration as required.
To communicate with key stakeholders with regard to medicines and supply including HPRA, HSE, suppliers and customers as applicable in conjunction with Pharma Ireland management team.
To have and maintain an in-depth knowledge of the regulatory and quality bodies and their requirements with whom we are required to interact with.
To ensure that you are sufficiently informed to enable you to contribute in an active and dynamic way when interfacing with your peers and management.
To maintain the company’s philosophy and management.
To manage and maintain good professional working relationships both internally and externally to the business.
Experience & profile:
Third Level qualification in pharmacy & registration with Pharmaceutical Society of Ireland
1-2 years experience in a community or hospital pharmacy role
Experience in a Quality, Regulatory or Pharmacovigilance role for pharmaceuticals desirable
RP and/or QP Status under EU Council Directive 2001/83/EC as amended desirable
Knowledge of EU healthcare legislation and quality standard requirements for pharmaceuticals
Excellent understanding of commercial implications of role
Can cope effectively with pressure and setbacks and maintain commitment in spite of opposition
The role demands a well-organised approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing. Reliability, IT literacy and the ability to plan and complete projects to set timelines is essentia
DCC Vital is an Equal Opportunity Employer
Full-time, permanent role
Available to work beyond normal office hours and weekends, including travel as required
Although the above is a description of the requirements of the role, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time.
Please note although the above is a description of the requirements of the role, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time.
Please note that all DCC Vital staff work within quality management systems and that all the above will apply to the product portfolio.
Company: DCC VITAL –
Company Location: Kilcoole, County Wicklow