Responsibilities:

Duties of a Qualified Person and/or Deputy
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 both company and the client company 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.

Qualifications/Experience:

B.Sc. Minimum or Pharmacy primary degree.
Greater than 3 years 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.

For further information please call Linda at 01 2784671 or email your CV in the strictest confidence to ldunne@thornshaw.com . Log on to www.thornshaw.com for more jobs.

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