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Job Ref.: 1695

Job Title: Medical Information and Patient Safety Specialist – Pharmaceuticals - Dublin - Urgent – December 2018

Sector: Medical Information

Location: Ireland, Dublin

Job Type: Permanent full-time

Job description:

Medical Information and Patient Safety Specialist – Pharmaceuticals - Dublin - Urgent – December 2018

Our client a major pharmaceutical company based in Dublin wish to appoint a Medical Information and Patient Safety Specialist to join their medical affairs team.

The position is a full time permanent role.

Purpose and Scope

The purpose of this role is to ensure legislative, IPHA code, Internal Code of Conduct & Quality norm compliance across designated business critical systems.

The medical department provides integral support to the business in terms of ensuring effective and compliant pre-promotion, promotion, supply and safety of pharmaceutical products.

Key Responsibilities

  • Ensure key Quality records are maintained in accordance with SOPs

  • Participate in conducting internal audits as required

  • Develop processes / author SOPs as required

  • Act as first line contact for Medical Information Enquiries

  • Ensure compliance with all product safety, regulatory affairs and pharmacovigilance requirements

    Key Tasks

  • Maintain key Quality process records for Training, Product complaints, SmPC/API updates and Grants & donations.

  • Collaborate with Quality Specialist to perform internal audit checks on other processes as required.

  • Receipt, correct documentation and follow-up as appropriate of all Medical Information Enquiries and Product Complaints

  • Liase with Medical Information Service Provider and Medical Advisors/Manager as appropriate

  • Dissemination and implementation of updates to SmPCs, APIs and PILs

  • Reporting of adverse events to drug safety unit Manager

  • Manage internal process for implementation of variations

  • Contribute to development of company SOPs as required.

  • Actively participate as part of the Drug Safety team, ensuring a Quality mindset is applied to all internal processes and documentation in order to ensure demonstrable due diligence.

  • Ensure all process documentation is maintained consistently and adequately for internal or external audit purposes.  Ensure follow up corrective actions for findings if any.

  • Assist in preparation of training materials when required

  • Ensure that the reconciliation between Medical Information function and Patient Safety is effective by performing adhoc review on reconciliation files

Candidate Requirements

  • Bachelor degree in science, pharmacy or nursing
  • Highly organised and detail oriented
  • Excellent communication and problem solving skills
  • 1-2 years’ experience in the pharmaceutical industry preferably in  medical information or drug safety
  • Strong commitment to compliance with the relevant rules and procedures, and to scientific quality and integrity.

An excellent salary plus benefits package will apply to the successful candidate.

For further information, please contact Paul Flanagan at Dublin 01 805 5522 or email your c/v in the strictest confidence to paul@pharmasolutions.ie

 

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