Pharmacovigilance Associate

Job Overview

Applications are invited for the position of a Veterinary Pharmacovigilance Associate within the Regulatory department.  The successful candidate will be reporting to the Pharmacovigilance Manager/Deputy QPPV.  He/she should be educated to a third level qualification or have at least 2 years’ experience in a busy administrative role.  Full Pharmacovigilance training will be provided, therefore no prior experience in this area is required, however it would be beneficial.  Preference for someone who has some experience in the animal health industry or a regulatory environment; however this is not a prerequisite for the role. 

Main Activities/Tasks

  • Undertake a range of administrative duties on behalf of the QPPV and Pharmacovigilance Manager with regards to the maintenance of the Pharmacovigilance System Masterfile (PSMF) and QMS including adverse event reporting and other Pharmacovigilance activities.
  • To provide a high level of administrative support to the QPPV and Pharmacovigilance Manager.
  • To ensure compliance with Standard Operating Procedures (SOPs), whilst adhering to the operational requirements and legislation appointed by Regulatory Authorities.
  • To liaise with global Regulatory Authorities, Distributors and Norbrook personnel on Pharmacovigilance issues (including quality investigations) on a daily basis, ensuring queries are responded to in a timely manner.
  • Accurate technical data entry including the receipt and processing of global adverse event reports and follow-ups on the Veterinary Pharmacovigilance system, ensuring timely submission to global regulatory authorities in compliance with internal procedures and global legislation.
  • To ensure compliance with internal departmental procedures and Key Performance Indicators. 
  • To assist in the maintenance of the Pharmacovigilance QMS and associated documentation.
  • To assist in the preparation of periodic reporting to applicable regulatory agencies whilst liaising with the QPPV, Deputy QPPV and/or Veterinarians to ensure timely submission.

Essential Criteria:

Applicants must therefore demonstrate the following essential criteria on their application form in order to be considered:

  • Educated to a third level qualification or have at least 2 years’ experience in a busy administrative role.
  • Highly organised with experience working in a busy office environment. 
  • The ability to work well under pressure and on their own initiative, whilst demonstrating a high degree of accuracy. 
  • A meticulous approach, attention to detail and excellent communication skills. 
  • Must be computer literate with excellent knowledge of Microsoft Word, Excel and Outlook software.

Duration: Full Time, Permanent

Location: Newry

Additional Information:

  • This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy.
  • Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
  • We regret that applications received after the closing date and time will not be accepted.

Norbrook Laboratories Limited employs a workforce with members of all sections of the community and is committed to appointing people purely on the basis of merit. In accordance with our equal opportunities policy, we would particularly like to welcome applicants from the Protestant Community.
 

  • Anywhere
  • Closing date: