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Details

Pharmacovigilance Specialist


Reference:BCHQ00000296 Location: Tipperary
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Pharmacovigilance

Pharmacovigilance Specialist

Our client, a Consultancy based in Munster, is seeking a PV Specialist to join their organisation on a permanent basis.


Responsibilities:



  • To complete the duties of a Qualified Person and/or Deputy (QPPV)

  • Writing of Periodic Safety Update Reports and searching for ADRs

  • Assessing adverse reactions for potential signals

  • Producing summary safety tables for Client review

  • Preparation and training for Regulatory Inspections

  • MedDRA coding

  • Understanding and helping with determining ADR reportability

  • SOP review and writing.

  • Compilation of Risk Management Plans.

  • Protects the assets of all parties within their responsibility by effectively and proactively managing emerging issues which impact the competitiveness of the licenses.

  • Builds and maintains strong relationships with all personnel within the Irish Medicines Board or appropriate competent authority to ensure ease of access and influence.

  • Be an authority on the regulatory framework in Ireland and Europe.

  • Supports EU regulatory initiatives and issues as appropriate.

  • Works collaboratively with other department colleagues to share best practice and information and ensure a consistent approach with both Competent Authority & within company.

  • Responsibility for the medical review and approval of medicinal product advertising and promotional materials for the Irish market as per client requirements.

  • Providing advice and support on Medical enquiries and other medical aspects relevant to the business.


Requirements:



  • B.Sc. Minimum or Pharmacy primary degree.

  • A number of years of experience in Regulatory Affairs in the Pharmaceutical Industry.

  • Strong commercial awareness and an innate ability to assess the commercial implications of decisions and advice.

  • Rounded knowledge of the national and EU regulatory framework.

  • Excellent written and oral communication skills.

  • Ability to project manage across a diverse and complex portfolio of products and priorities.

  • Ability to get on with people, to influence people both internally and externally and to achieve objectives.

  • Above average attention to detail and solid interpersonal, communication and organisational skills required.

  • Ability to work independently with minimal supervision.

  • Motivated self-starter.

  • Ability and desire to progress.


If you would like further information you can contact:

Brian Christensen | Tel: +353 (0) 1 685 4747