VACANCY in HOLLAND: Pharmacovigilance Alliance Manager

Astellas Pharma - Leiden (The Hague Area, Netherlands)

Job Description

Pharmacovigilance Alliance Manager
Location: Leiden, The Netherlands
In this role:
You will be responsible for the execution of the outsourced activities in line with the GPV outsourcing strategy. You will be the key contact for day to day interaction with the vendor and oversee the in-house activities related to the outsourced function. You will ensure that all outsourced activities are executed according to contract, procedures and budget. You will oversee the compliance of the outsourced activities and will ensure corrective and preventive actions are implemented and/or escalated in case of partner non-compliance. You will also manage operational interactions with License Partners.

The key pillars of this role are:
• Organization and planning
• Relationship management
• Audit/inspection readiness and response
• Quality and compliance management

Your personal qualifications:
• BS/MS degree in (Bio)medical or Life Sciences;
• At least 5 years of PV experience with Masters degree, or 7+ years experience with BS degree;
• Technical expert with in depth understanding of Pharmacovigilance and associated processes;
• In depth knowledge of regulatory requirements and strong industry perspective;
• Strong project management, negotiation and problem solving skills;
• Excellent communication skills in English, both verbally and in writing.

We offer:
• A challenging and diversified job;
• Good career opportunities;
• Inspiring work climate;
• Attractive remuneration;
• Attractive relocation package.

About Astellas:
Astellas is an international pharmaceutical company employing over 16,000 people worldwide and with combined global sales of over 7 billion euro. The company’s European headquarters are based in London, with affiliates throughout Europe working in production, sales & marketing, and research & development. With almost 4,000 employees, Europe is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Dermatology, Transplantation, Anti Infectives, Pain Management and Oncology.

The Mirai House, located in Leiden Bio Science Park (the Netherlands) is home to the European R&D organization focusing on the development of medicines in the areas of Pain, Urology and Diabetes/Metabolic diseases.
An R&D investment budget of 15-20% is evidence of the company’s commitment to improving the health of people worldwide through the provision of innovative and reliable products. The Mirai House is also hosting Astellas Pharma Netherlands (the Dutch affiliate) and Astellas Pharma International. Astellas Pharma International is present in the Near & Middle East, Africa and some other selected countries.

Within the Pharmacovigilance Operations section of our Global Pharmacovigilance department (GPV) we are in search of a Pharmacovigilance Alliance Manager.

Interested?
For more information about this position you can contact Cherr van Dormolen, 31 (0)6 2277 5467.

If you are interested in this position please send us your application by using the link (copy and paste the link in your internetbrowser):
http://astellas.heeft-vacatures.nl/P/14158/V89/solliciteren

Or use the 'Apply on Company Website' button.

Agency calls not appreciated.
Keywords: Drug Safety, Pharmacovigilance, Alliance Management, Vendor Management

VACANCY: Full Professor of Veterinary Diagnostic Imaging

Full Professor of Veterinary Diagnostic Imaging (1,0 fte)

Specifications - (explanation)

Location	University Utrecht, Faculty of Veterinary Medicine
Function types	Professors, associate professors, assistant professors and lecturers
Scientific fields	Natural Sciences, Health
Hours	40.0 hours per week
Salary	€ 4904 - € 7142
Education	Doctorate
Job number	480344
Translations	en

Apply for this job within 19 days

Job description

You will lead and work within the division of Diagnostic Imaging. The division performs diagnostics on patients of the departments of 'Clinical Sciences of Companion Animals' and 'Equine Sciences', on external clients from practitioners and on experimental animals. The division currently comprises 8 staff members and 11 technical support. The division has state-of-the-art facilities. The services of the division cover the entire broadness of the field.
The full professor is responsible for the overall quality of the work and the associated research and teaching programmes in both areas regardless of her or his primary expertise

Your primary tasks are:

• organizing and directing the diagnostic services in close collaboration with the clinical directors;
• innovating diagnostic imaging in veterinary practice in close collaboration with the medical imaging department of the University Medical Centre Utrecht (UMCU);
• coordinating and co-developing the innovation and educational activities of the division;
• directing the research programme of the division in the context of the faculty-wide programme;
• distributing scientific results via publications in high-ranking scientific journals and to other stakeholders;
• acquiring extramural research funds;
• contributing to the faculty organization and the well-being of the scientific community  by participation in management and faculty committees.

Requirements

We are searching for a colleague who:

• has a DVM and PhD degree and has broad experience with veterinary diagnostic imaging in an academic clinical setting, and is a diplomate of the European or American College of Veterinary Diagnostic Imaging;
• is internationally recognized as an outstanding expert in the field of diagnostic imaging;
• has a clear vision on the development of the field of diagnostic imaging;
• has excellent teaching skills and is familiar with veterinary curricula;
• has an excellent track record of publishing in high-ranking international scientific (bio)medical and veterinary journals on a regular basis and is regularly invited for keynote lectures at international conferences;
• has a proven track record in acquisition of funds;
• has a ‘senior-level academic teaching and/or research qualification’ or equivalent;
• has excellent communication and proven management skills and inspires co-workers to achieve excellence;
• is able to speak the English language fluently and is willing to learn and speak the Dutch language; 

Conditions of employment

We offer a full-time permanent position.

The gross salary varies, depending on previous qualifications and experience, and will amount between € 4.904,- and € 7.142,- gross per month (full time appointment in scale H2 of the Collective Labour Agreement of the Dutch Universities).
Salaries are supplemented with a holiday bonus of 8 % and a year-end bonus of 8.3 % per year. In addition, there are outstanding secondary benefits such as a minimum of 29 days holiday per year, study facilities, and a pension plan. More information on our terms of employment.

Organisation

Utrecht University’s Faculty of Veterinary Medicine (UUFVM) is the only Veterinary School in the Netherlands and belongs to the international top in education, research and veterinary medical patient care. UUFVM is one of the few European veterinary schools accredited by the American and Canadian Veterinary Medical Associations and the European Association of Establishments for Veterinary Education.
The faculty employs approximately 1000 veterinarians, scientists and support staff and counts 1500 students. To facilitate coherence and the attainment of ‘critical mass’, its research functions are coordinated by the Institute of Veterinary Sciences and the Graduate School of Life Sciences. Further information about UUFVM and Utrecht University is available via the website www.uu.nl
 

Additional information

Informal inquiries should be directed to Prof dr. J.Rothuizen, phone: + 31 30 253 1692; j.rothuizen@uu.nl.
Candidates may be invited for an assessment procedure.
Utrecht University is an equal opportunity employer and is committed to increasing the diversity of its faculty. It welcomes nominations of and applications from women and members of minority groups.

More information about employer Utrecht University on AcademicTransfer. Direct link to this job opening: www.academictransfer.com/15227

Bron: http://www.academictransfer.com/employer/UU/vacancy/15227/lang/en/

Job Erasmus MC - PhD student for Biomedical Imaging Group Rotterdam (BIGR) - on the project Imaging biomarkers for oncology drug development

PhD student for Biomedical Imaging Group Rotterdam (BIGR) - on the project Imaging biomarkers for oncology drug development

Specifications - (explanation)

Location	Rotterdam, 3015 CE, The Netherlands
Function types	PhD positions, Research, Development, Innovation
Scientific fields	Health
Hours	36.0 hours per week
Salary	€ 2107 - € 2700
Education	University Graduate
Job number	12.06.12.TD
Translations	en

Apply for this job within 60 days

Job description

We have one open PhD position on an exciting project in which new imaging techniques will be developed for measuring the response of tumour cells to treatment. Such imaging biomarkers are crucial in the phase of drug development, for assessing whether a potential new medicine is effective or not. The project is part of an international research programme, called QuIC-ConCePT, in which we collaborate with many partners from both academia and pharmaceutical industry. The European Journal of Cancer recently published a series of articles that introduce the QuICConCePT project: European Journal of Cancer, vol. 48 no. 4, March, 2012 (contact vacancies@bigr.nl if you do not have access). The candidate will be responsible for the development and validation of automated image analysis methods. The main focus will be on image registration, i.e. the alignment of images acquired at different time points (to monitor change) and/or with different imaging modalities (e.g. MRI, PET). Newly developed algorithms will be integrated in the open source Elastix software (elastix.isi.uu.nl).

Requirements

Candidates must have a Master’s degree in a technical field (Mathematics, Physics, (Biomedical) Engineering, Informatics etc.). Experience with programming is an advantage. You should be able to work in a multi-disciplinary team. Strong theoretical skills and affinity with experimental work are required.

Conditions of employment

Our institute is internationally at the forefront of biomedical imaging and offers a dynamic, challenging, and cooperative research environment. As a PhD student you will get a temporary position for four years. The gross monthly salary amounts € 2.107,- in the first year and increases to € 2.700,- in the fourth year. The terms of employment are in accordance with the Collective Bargaining Agreement for University Medical Centers (CAO UMC).

Contract type: Temporary, 4 years

Organisation

Erasmus MC

Erasmus MC inspires and is challenging. You create your own opportunities in this University Medical Center. Whether it concerns learning and work or work and learning/continued learning. Each and every day our enthusiastic staff devote themselves to excellent, dedicated patient care, pioneering medical research and valued education. A conscious choice for work that matters, both nationally and internationally, at the heart of our multicultural home base ofRotterdam. Where attention to individual staff member comes naturally. Working from the heart. Together with people, for people: ‘patient-centered care’!

Department

Biomedical Imaging Group Rotterdam

The Biomedical Imaging Group Rotterdam (BIGR; www.bigr.nl) at the departments of Medical Informatics and Radiology performs innovative fundamental and applied research to develop and validate advanced techniques for the processing and analysis of large, complex, and heterogeneous medical and biological image data sets.

Additional information

Requests for information should be directed to Dr. Stefan Klein via e-mail: vacancies@bigr.nl.

More information about employer Erasmus MC (University Medical Center Rotterdam) on AcademicTransfer. Direct link to this job opening: www.academictransfer.com/13481

Bron: http://www.academictransfer.com/employer/EMC/vacancy/13481/lang/en/

2 PhD Students Tailored Treatment and systems biology of Chronic Heart Failure

Specificaties - (uitleg)

Functietypes	PhD positions
Wetenschappelijke discipline	Health
Uren	36.0 uren per week
Salaris	€ 2107 - € 2700
Werk-/denkniveau	Higher Professional Education +
Vacaturenummer	MR0329
Vertalingen	en

Solliciteer binnen 28 dagen op deze vacature

In Europe the prevalence of heart failure (HF) is about 10-20 in 1000 persons and the prevalence is rising due to the ageing European population. In persons over 75 years of age about 10% is affected. Despite major improvements in the last decennium, prognosis and quality of life of CHF patients is limited. One of the reasons is that response to pharmacological treatment varies between individuals. To investigate markers of treatment-response, 5000 HF patients will be followed in the BiOSTAT-CHF project for mortality, hospitalization and their quality of life. Demographic data, established biomarkers and new genomic and proteomic biomarkers will be combined in prognostic models to predict treatment-response. The BiOSTAT-CHF is an EU-funded project with collaborators from France, Greece, Germany, Italy, the Netherlands, Norway, Poland, and the UK (www.biostat-chf.eu). 
Within this project there are two vacant positions for PhD students.
1. The primary aim of the first project is the development of prognostic models for the response to pharmacological treatment by CHF patients. The prognostic models concern mortality and morbidity of the patients and will be based on well known statistical methods using established risk factors of CHF as well as new biomarkers identified from genome-wide and proteome-wide biomarker identification. The prognostic models will be developed from the primary BiOSTAT-CHF sample and will be validated in a well characterized second sample. 

2. The primary aim of the second project is the development of a systems biology approach to link the multidimensional clinical phenotypes of the CHF-patients and their outcome to genetic markers, gene transcription and translation levels in peripheral blood cells. Aim is to derive concise causal pathogenetic pathways that link the genetic and molecular data to the different CHF phenotypes and outcomes. For this project it is necessary to develop new statistical and bioinformatics methods.

Functie-eisen

We look for investigators with a master of science in medicine, biomedical/life sciences or (clinical) epidemiology (project 1) and investigators with a master of science in bioinformatics or mathematics/statistics (project 2). For both projects a very good command of the English language (spoken and in writing) is required because of frequent and intensive contacts with partners in the BiOSTAT-CHF project. Experience with clinical research and CHF is preferred but not a prerequisite. Candidates must be willing to travel to participating centers across Europe.

Arbeidsvoorwaarden

- A full time PhD position with the possibility to participate in the exiting BiOSTAT-CHF project and to write PhD-theses on developing future tools for personalized medicine and understanding molecular biological underpinnings of chronic heart failure.
- Employment by the AMC Medical Research foundation for a period of 12 months, with possible extension of the contract to 48 months.
- A gross salary will be € 2.107,00 per month in the first year, with an increase to the maximum of € 2.700,00 per month in the fourth year. In addition the AMR BV has an End of Year Bonus of 8.3% and a holiday payment of 8% of the gross yearly salary. 
- As a PhD candidate, you are entitled to follow courses provided by the AMC Graduate School.

Dienstverband: Temporary, 12 months, with possible extension of the contract to 48 months