Clonmel, Co. Tipperary – Part-Time/Permanent

Niche Generics Limited is a generic pharmaceutical company whose products are registered and marketed in the UK, EU, South Africa, Australia and New Zealand.  We currently have a vacancy for an experienced, part-time Pharmacovigilance Officer based in our office in Clonmel, Co. Tipperary.

The Pharmacovigilance Officer will liaise with external contract pharmacovigilance service providers and licensing partners to co-ordinate activities in compliance with current EU and UK requirements.

The ideal candidate will be a life science or pharmacy graduate, with a minimum of three years’ experience in pharmacovigilance.  Key responsibilities will include:


  • Overseeing maintenance of the Pharmacovigilance System Master File (PSMF)
  • Writing and updating in-house pharmacovigilance SOPs
  • Provision of information to contract pharmacovigilance service providers related to MAs
  • Reporting to QPPV to ensure QP oversight in relation to safety variations
  • Receipt and co-ordination of medical queries and ADRs
  • Review and co-ordination of Safety Data Exchange Agreements
  • Review of PRAC/regulatory authority updates related to safety information
  • Assisting with pharmacovigilance audits and inspections
  • Review pharmacovigilance compliance reports and change notifications received from service providers
  • Review documentation prepared by pharmacovigilance service providers for regulatory submissions (eg. RMPs, ACOs, CESs)
  • Participation in Drug Safety Review Meetings with pharmacovigilance service providers
  • Co-ordinating annual pharmacovigilance staff training


A sound knowledge of the key aspects of the European and UK pharmacovigilance systems is required.  Strong communication and interpersonal skills are essential together with a methodical approach to working and a high degree of computer literacy.

A competitive salary commensurate with experience is offered together with a generous benefits package.

To apply for this position please send your CV to or fill the application form below.


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