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Details

Pharmaceutical Assessor


Reference:ASIO-582635 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Pharmaceutical Assessor
Our client, a large regulatory body, are currently recruiting for two Pharmaceutical Assessors to join their team. This role is based in Dublin city centre and the ideal candidate will have experience dealing with marketing authorisation applications.

Responsibilities
• Conduct scientific evaluation of quality data submitted in support of applications for marketing authorisation for human medicinal products containing new chemical entities or established active ingredients
• Carry out analysis of their risk/benefit profiles reporting and forming conclusions in respect of their suitability for use as human medicinal products as well as consideration of the public health consequences of their use
• Conduct scientific evaluation of quality data submitted in support of national applications for marketing authorisations, including Parallel Products, centralised applications to the EMA for marketing authorisations and EU applications
• Prepare assessment reports on applications for marketing authorisation for human medicinal products and submission of reports to other EU member states when
• Analysis in the context of public health, of risk-benefit profiles in respect of applications for marketing authorisation; making recommendations and preparation and presentation of reports to the Board, Advisory Committees and Sub-Committees or the Management Committee
• Assist the Pharmaceutical Assessment Manager and other managers in the Pharmaceutical Assessment section in ensuring the accuracy of relevant data inputted in the computer databases and information systems

Requirements
• Degree in pharmacy, chemistry or other relevant scientific discipline
• Minimum of 3 years relevant industrial, regulatory and/or research experience in the pharmaceutical industry, a regulatory authority or in a related field
• Industrial / regulatory background and the necessary breadth of experience to review the quality sections of a marketing authorisation application
• Postgraduate qualification in a relevant scientific discipline or an additional three years relevant experience
• Proven track record of working within multidisciplinary teams
• Proven ability demonstrating excellent interpersonal, communication and presentation skills
• Proven ability to meet deadlines
• Direct experience working with stakeholders/customers
• Demonstrated initiative and team working capabilities
• Demonstrated ability to think critically and independently

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252