Pharmacokinetics Assessor,
Department
Medical and Healthcare Products Regulatory Agency
Business Area
Licensing
Number of Vacancies
1
Location: Region
London
Location: City/Town
London
Location: Building/Site
Victoria, London
Grade
SEO
Equivalent Grade
SEO progression to Grade & on Achieving Accreditation
Salary Minimum
37175
Salary Maximum
52618
Type of Role
Medical
Science
Other
Science
Other
Reserved/Non Reserved posts
This is a Non Reserved post and is therefore open to UK, British Commonwealth and European Economic Area (EEA) Nationals and certain non EEA members
Security
Basic check
Criminal Records Bureau Check
This post does not require a Criminal Records Bureau Check
Is a medical required for this post?
Yes
Job Description
The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe.
Purpose of Role:
The Licensing Division is responsible for the quality, safety and efficacy evaluation of all applications for medicinal products to be authorised for the U.K. through national and E.U. Community procedures. To reflect the importance of pharmacokinetic data in the evaluation of clinical safety and efficacy and the increasing use of pharmacometrics in drug development we have a new post for a pharmacokineticist in the Division to integrate knowledge of pharmacokinetics into the assessment of safety and efficacy.
Key Responsibilities:
Your scientific and professional expertise in pharmacokinetics will be vital in this challenging role, as you will work alongside clinical pharmacologists, clinicians and biostatisticians to evaluate the efficacy and clinical safety of a range of products including the latest new drugs, generic drugs and clinical trial products. You will provide advice on pharmacokinetic issues to colleagues within the Division and will review pharmacokinetic aspects of clinical trial data, preparing reports and recommendations which are highly influential in bringing new medicines to the market. You will need to interact with colleagues in other European regulatory agencies, the European Medicines Agency and to present your considerations to U.K. and European multi-disciplinary advisory committees. You will also be involved in the development of new regulatory guidelines and the provision of scientific advice on drug development programmes.
Essential criteria to apply: (shortlist and interview criteria)
Education/qualification and training:
1. Degree and higher qualification in a relevant pharmaceutical science. The first degree or higher qualification must demonstrate a thorough understanding of pharmacokinetic theory.
2. Practical experience in the application of pharmacokinetic theory including a strong theoretical understanding and demonstrated application of population PK/PD principles, analysis methods, estimation methods and good modelling practices. Demonstrated experience in use of PK/PD software packages such as WinNonlin, NONMEM, Adapt, S-Plus or R.
Knowledge/skills:
3. Demonstrated experience of contributing to the design, conduct, analysis and interpretation of clinical studies and preparation of reports, reviews or manuscripts for regulatory submissions or publication in peer-reviewed journals (PSG 2).
4. Demonstrated awareness of drug development and regulatory processes.
5. The ability to critically analyse clinical/scientific information, make sound judgements on its value and write authoritative reports to meet required timelines (PSG 2 & 4).
6. Good communication, presentational and organisational skills. Interpersonal skills to facilitate team-working, consulting and co-operating with colleagues in different areas of expertise and those in other parts of the Agency (PSG 1)
The above criteria will be used when assessing your suitability for the position.
When completing your application form you need to address only the assessment criteria detailed in the essential criteria table above.
If you are invited to attend an interview you will be assessed against the entire core PSG and specialist PSG requirements detailed in the advert. Therefore, please make yourself familiar with these requirements through reviewing the accompanying PSG documents.
We are an equal opportunities employer and welcome applications from suitably qualified people regardless of age, gender, sexual orientation, marital status, race, religion, politics or disability.
Purpose of Role:
The Licensing Division is responsible for the quality, safety and efficacy evaluation of all applications for medicinal products to be authorised for the U.K. through national and E.U. Community procedures. To reflect the importance of pharmacokinetic data in the evaluation of clinical safety and efficacy and the increasing use of pharmacometrics in drug development we have a new post for a pharmacokineticist in the Division to integrate knowledge of pharmacokinetics into the assessment of safety and efficacy.
Key Responsibilities:
Your scientific and professional expertise in pharmacokinetics will be vital in this challenging role, as you will work alongside clinical pharmacologists, clinicians and biostatisticians to evaluate the efficacy and clinical safety of a range of products including the latest new drugs, generic drugs and clinical trial products. You will provide advice on pharmacokinetic issues to colleagues within the Division and will review pharmacokinetic aspects of clinical trial data, preparing reports and recommendations which are highly influential in bringing new medicines to the market. You will need to interact with colleagues in other European regulatory agencies, the European Medicines Agency and to present your considerations to U.K. and European multi-disciplinary advisory committees. You will also be involved in the development of new regulatory guidelines and the provision of scientific advice on drug development programmes.
Essential criteria to apply: (shortlist and interview criteria)
Education/qualification and training:
1. Degree and higher qualification in a relevant pharmaceutical science. The first degree or higher qualification must demonstrate a thorough understanding of pharmacokinetic theory.
2. Practical experience in the application of pharmacokinetic theory including a strong theoretical understanding and demonstrated application of population PK/PD principles, analysis methods, estimation methods and good modelling practices. Demonstrated experience in use of PK/PD software packages such as WinNonlin, NONMEM, Adapt, S-Plus or R.
Knowledge/skills:
3. Demonstrated experience of contributing to the design, conduct, analysis and interpretation of clinical studies and preparation of reports, reviews or manuscripts for regulatory submissions or publication in peer-reviewed journals (PSG 2).
4. Demonstrated awareness of drug development and regulatory processes.
5. The ability to critically analyse clinical/scientific information, make sound judgements on its value and write authoritative reports to meet required timelines (PSG 2 & 4).
6. Good communication, presentational and organisational skills. Interpersonal skills to facilitate team-working, consulting and co-operating with colleagues in different areas of expertise and those in other parts of the Agency (PSG 1)
The above criteria will be used when assessing your suitability for the position.
When completing your application form you need to address only the assessment criteria detailed in the essential criteria table above.
If you are invited to attend an interview you will be assessed against the entire core PSG and specialist PSG requirements detailed in the advert. Therefore, please make yourself familiar with these requirements through reviewing the accompanying PSG documents.
We are an equal opportunities employer and welcome applications from suitably qualified people regardless of age, gender, sexual orientation, marital status, race, religion, politics or disability.
Job Description URLs
Competencies
Please see the essential criteria above and refer to the relevant PSG Guidance document provided on our website. To request this please email jobs@mhra.gsi.gov.uk or go to our external jobs website to download: http://www.mhra.gov.uk/Aboutus/Workingforus/Currentjobvacancies/index.htm
Qualification(s)
1. Degree and higher qualification in a relevant pharmaceutical science. The first degree or higher qualification must demonstrate a thorough understanding of pharmacokinetic theory.
2. Practical experience in the application of pharmacokinetic theory including a strong theoretical understanding and demonstrated application of population PK/PD principles, analysis methods, estimation methods and good modelling practices. Demonstrated experience in use of PK/PD software packages such as WinNonlin, NONMEM, Adapt, S-Plus or R.
2. Practical experience in the application of pharmacokinetic theory including a strong theoretical understanding and demonstrated application of population PK/PD principles, analysis methods, estimation methods and good modelling practices. Demonstrated experience in use of PK/PD software packages such as WinNonlin, NONMEM, Adapt, S-Plus or R.
Working Pattern
This post is full time and not suitable for part time or job share applicants
Employment Terms: Post Type
Permanent
Employment Terms: Hours
37
Contact and further details
Additional Information
Please note that all positions in the MHRA require good all round I.T. skills, particularly MS Office. However, some positions require more specialist skills. Please refer to the essential criteria for the post above for more detailed information about the I.T. requirements of this post.
Please note that the full salary pay range for these roles is £37,175 to £52,618 (Progression to grade 7 on achieving accreditation £48,799 to £61,976) Progression to the maximum of the salary range will be dependent on performance and Government policy on pay.
If these challenges inspire you, you can download our application form, HR information form and further information at our website at www.mhra.gov.uk. You can send your completed application form and HR information form, quoting the reference number via email to jobs@mhra.gsi.gov.uk, fax 0203 118 98200 or post to the HR Department, Floor 4-C-O, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ. We strongly encourage electronic applications.
All civil servants work within the boundaries of the Civil Service Code. The Code sets out the duties and responsibilities of all civil servants. Please click on the link for more information http://www.civilservice.gov.uk/about/values/cscode/index.aspx
Please note that if you do not receive a response to your application within 6 weeks after the closing date you have not been selected for interview. Due to the high volume of applications we receive we do not provide feedback to candidates at application stage.
Please note that all positions in the MHRA require good all round I.T. skills, particularly MS Office. However, some positions require more specialist skills. Please refer to the essential criteria for the post above for more detailed information about the I.T. requirements of this post.
Please note that the full salary pay range for these roles is £37,175 to £52,618 (Progression to grade 7 on achieving accreditation £48,799 to £61,976) Progression to the maximum of the salary range will be dependent on performance and Government policy on pay.
If these challenges inspire you, you can download our application form, HR information form and further information at our website at www.mhra.gov.uk. You can send your completed application form and HR information form, quoting the reference number via email to jobs@mhra.gsi.gov.uk, fax 0203 118 98200 or post to the HR Department, Floor 4-C-O, 151 Buckingham Palace Road, Victoria, London SW1W 9SZ. We strongly encourage electronic applications.
All civil servants work within the boundaries of the Civil Service Code. The Code sets out the duties and responsibilities of all civil servants. Please click on the link for more information http://www.civilservice.gov.uk/about/values/cscode/index.aspx
Please note that if you do not receive a response to your application within 6 weeks after the closing date you have not been selected for interview. Due to the high volume of applications we receive we do not provide feedback to candidates at application stage.
The Civil Service is committed to providing services which embrace diversity and which promote equality of opportunity. We also offer a guaranteed interview scheme for disabled applicants who meet our minimum selection criteria.
We will not tolerate discrimination on any of the following: gender, marital status, sexual orientation, race, colour, nationality, religion, age, disability, HIV positivity, working pattern, caring responsibilities, trade union activity or political beliefs - or any other grounds.
External applicants should note that for posts in Northern Ireland, applications from the Roman Catholic community are particularly welcomed as this group is currently under-represented in our workforce.
We will not tolerate discrimination on any of the following: gender, marital status, sexual orientation, race, colour, nationality, religion, age, disability, HIV positivity, working pattern, caring responsibilities, trade union activity or political beliefs - or any other grounds.
External applicants should note that for posts in Northern Ireland, applications from the Roman Catholic community are particularly welcomed as this group is currently under-represented in our workforce.
Closing date
22 Feb 2012
Follow link to apply
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