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June 20 2018

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Pharmacovigilance agent:Fannin Ltd.

Job description:

Pharmacovigilance agent

Fannin Ltd.


   » Roscommon
   » Not disclosed
   » Permanent full-time
   » Updated 13/06/2018
   » Ruairi Fitzmauice this job is expired SaveSave Apply Now

Job detail


The PV agent is responsible for carrying out pharmacovigilance activities in conformity with Good Pharmacovigilance Practices and company Quality Management Systems for the DCC Vital group and clients where applicable.
 
DCC Vital, DCC Healthcare & DCC plc

DCC Vital is a subsidiary of DCC Healthcare, an operating division of DCC plc. DCC Vital is a leading healthcare business in Britain and Ireland with sales in excess of £350 million, over 1,000 employees and an ambition to be one of the leading players in the supply of products and services to the healthcare sector in Europe. DCC Vital is focused on driving organic growth in its existing businesses and identifying new growth opportunities that strengthen and expand its product range, broaden its geographical reach and improve its business.
DCC Vital operates across three key divisions - DCC Vital Pharma, DCC Vital Medical Devices and DCC Vital Logistics:
Athlone Laboratories has been a part of DCC Vital since Feb 2013 and is one of the leading manufacturers of oral beta-lactam antibiotics in Western Europe.

listing title: Pharmacovigilance agent

Job location: Roscommon

Reporting to: Pharmacovigilance Manager/QPPV

Summary
The PV agent is responsible for carrying out pharmacovigilance activities in conformity with Good Pharmacovigilance Practices and company Quality Management Systems for the DCC Vital group and clients where applicable.

Principal tasks and The main responsibilities are:
   » Screen worldwide (local) scientific literature on a weekly basis and evaluate significant information for inputting on to an internal database.
   » Evaluate adverse event reports received directly from regulatory authorities and input significant reports onto an internal database
   » Process safety data arising from all source as per SOPs
   » Report safety data using EudraVigilance
   » Input into extended EudraVigilance Medicinal Product Dictionary
   » Prepare and participate in regular signal detection meetings
   » Prepare and ensure submission of PSURs and Risk Management Plans in a timely manner.
   » Update Pharmacovigilance System Master File as required.
   » Ensure identified safety variations are planned, tracked and sent as per set timelines in conformity with the legislation.
   » Respond to medical information queries
   » Respond to queries form regulatory authorities
   » Review product information, prepare Addendum to Clinical Overview as required
   » contact with the Regulatory Department to ensure label updates arising from Pharmacovigilance activities are implemented in a timely fashion.
   » Prepare weekly reports for the Regulatory Manager and QPPV.
   » Ensure compliance with Volume 9A of The Rules Governing Medicinal Products in the EU and GVP modules, Reg 1235/2010, Reg 520/2012 and directive 2010/84/EU as applicable, and also the company procedures
   » Identify and implement practices to improve the Pharmacovigilance system including review of SOPs as required.
   » Optimise the use of resources at all times.
   » Participate and assist in the training of Pharmacovigilance personnel.
   » Provide Pharmacovigilance support and advice to significant departments.
   » Make recommendation relating to general improvements of the business.
   » Attend external meetings/training courses to maintain/improve overall expertise of Pharmacovigilance procedures, guidelines and directives.
   » Complete any other tasks as considered necessary by the Company.
Qualifications & practice:
   » Third Level qualification in a scientific discipline
The function demands a well-organised approach, underpinned by the capability to communicate effectively with people at all levels, both verbally and in writing. Relicapability, Information technology literacy and the capability to plan and complete projects to set timelines is essential.

Other Information:
   » Full-time, permanent function
   » In addition candidates should be:At times, may be required to work beyond normal working office hours

Although the above is a description of the requirements of the function, as stated in your contract of employment, you may be required to carry out other reasonable tasks as the Company may require from time to time.

Please note that all Athlone Laboratories staff work within a quality management system and that all of the above will apply to the product portfolio .

ATHLONE LABORATORIES IS AN EQUAL OPPORTUNITY EMPLOYER

Ref: 931504
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Fannin Ltd.


   »  


   » Fannin House, South County Business Park, Leopardstown, Dublin 18
   » +353 1 2907000
   » http://www.fannin.ie



Skills:

Job Category: Customer Service [ View All Customer Service Jobs ]
Language requirements:
Employment type:
Salary: Unspecified
Degree: Unspecified
Experience (year): Unspecified
Job Location: Roscommon
Company Type Employer
Post Date: 06/13/2018 / Viewed 11 times
Contact Information
Company: Fannin Ltd.


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