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Job Ref.: 1673

Job Title: Product Complaints Co-Ordinator - Pharma/Medical Devices - 2 Year Contract - Dublin West - September 2018 - Urgent

Posted Date: 25/09/2018

Sector: Compliance

Location: Ireland, Dublin West

Job Type: Temporary / Contract

Job description:

Product Complaints Co-Ordinator - Pharma/Medical Devices - 2 Year Contract - Dublin West - September 2018 - Urgent

Our client a major commercial Pharma/Medical devices company based in Dublin West (Ballymount Area) wish to appoint a Product Complaints Co-Ordinator to join their Regulatory Affairs team.

The position is a 2-year contract role with a view to becoming permanent after that.

Role & Responsibilities:

  • Management of product complaints for products on the Irish market, from initial receipt through to closure, in conjunction with the company’s Global Complaints Departments and in accordance with all relevant EU legislation, HPRA Guidelines and company specific Standard Operating Procedures.

  • Document and maintain the complaint files for all reports received.

  • Prompt communication of every complaint received to the Global Complaints Department and escalate serious product complaint issues, as necessary, to the relevant people both locally and globally, within the required timeframes.

  • Liaise with customers, in collaboration with the Sales/Marketing teams, regarding product quality issues and also in relation to medical/technical/clinical queries, ensuring an accurate and prompt response.

  • Review the product complaint investigation reports and document letters for the customers to relay the investigation results.

  • Provide periodic training, as required, to all relevant personnel on the handling of product quality complaints.

  • Contribute to the documentation and review of local procedures for product quality complaints.

  • Attend and partake in internal and external audits related to your job.

  • Support Pharmacovigilance, Medicovigilance and Compliance activities as directed when required.

Skills & Experience Requirements:

  • A degree in a life science or pharmacy discipline.

  • 2 years work experience in a compliance environment and a good understanding and working knowledge of GxP.

  • Familiarity with relevant Legislation, Regulations and Guidelines applicable in Ireland and the EU.

  • Proficiency in the English language with strong verbal and written communication skills is essential.

  • Ability to process technical information.

  • Accuracy and excellent attention to detail.

  • Excellent organisational skills.

  • Good interpersonal skills.

  • Computer skills (Microsoft Word, Excel; SAP an advantage).

An excellent salary circa 40-42k per annum plus benefits package will apply to the successful candidate.

For further information, please call Paul Flanagan at Dublin +353 1 8055522 or email your c/v in the strictest confidence to paul@pharmasolutions.ie asap

 

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