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

PhD Student EuroSkinGraft

Job description

The PhD student will be part of the European FP7 research consortium EuroSkinGraft to develop skin-regenerative therapies (e.g. for the treatment of burns), and to test three promising skin substitutes skin substitutes in the clinic (phase I and phase II trials; adults and children).
The tasks of the PhD student in this project will include comprehensive molecular evaluation of the clinical performance of the skin substitutes, i.e. biochemical, structural and molecular-biological evaluation. Emphasis will be on microarray analysis, including bioinformatics. New standards for the evaluation of skin substitutes will be set based on high density gene expression microarrays and gene ontology analysis. These data will be combined with all other data obtained in the project by other partners in order to obtain a comprehensive molecular evaluation of the clinical performance of the skin substitutes applied.
The European partners in the project will at least meet yearly to discuss the progress of the project. 

Requirements

We are looking for an enthusiastic PhD student with an MSc in Biology / Life Sciences and with affinity for both fundamental and clinical research. Your working style can be described as independent with a high degree of initiative, and well-structured. You are a team player who can operate within a multidisciplinary environment. Expertise in the following areas is highly recommendable: gene expression/microarray analysis (including bioinformatics and statistics), protein biochemistry and (immuno)histology. 

Conditions of employment

Maximum all-in yearly salary on full time basis is € 38,000 gross

Organisation

Radboud University Nijmegen Medical Centre (RUN MC)

Nijmegen www.umcn.nl/ UMC St Radboud
Radboud University Nijmegen Medical Centre (RUN MC) is a leading academic centre for medical science, education and health care. Knowledge forms the heart of our organisation, connecting research, education and patient care. Over 10,000 staff and 3,500 students are committed and ambitious to contribute to the future of health care and medical science.
Driven by knowledge, empowered by people.

Department

Biochemistry

The Department of Biochemistry is devoted to translate biomedical research into medical practice. A major focus of the department is to make smart scaffolds to stimulate/generate new organs. Tissue engineering and regenerative medicine are focus areas within the research institute Nijmegen Centre for Molecular Life Sciences (NCMLS).  

Additional information

You will be trained to develop yourself tot become an independent researcher. You will report your results in international medical journals with the ultimate goal to obtain the PhD degree.

For more information please contact:
Dr. Toin van Kuppevelt, associate professor, +31 (0)24 3616759, a.vankuppevelt@ncmls.ru.nl
or
Dr. ir. Willeke Daamen, assistant professor, +31 (0)24 3614303, w.daamen@ncmls.ru.nl 

More information about employer Radboud University Nijmegen Medical Centre (RUN MC) on AcademicTransfer. Direct link to this job opening: www.academictransfer.com/13018

Consultant in Life Sciences

Bedrijf:

Altran BV

Geplaatst op:

maandag 23 januari 2012

Standplaats:

Schiphol

Functieomschrijving

Altran Consultants provides pharmaceutical and biotechnological consulting services throughout the different steps of drug manufacturing. Our Life Sciences division delivers our clients high-value service offers, from organizational and regulatory audits to global project management assistance, guaranteeing them adapted solutions in compliance with pharmaceutical, biotechnological and GMP-related industries specific demands:

• Audit & Compliance;
• Quality Assurance;
• Quality Intelligence;
• Validation Life cycle;
• Supply Chain Assurance;
• Regulatory Affairs;
• Process optimization; and
• Project Management.

Our clients are the major international pharmaceutical and biotechnological companies located throughout Europe (Belgium, France, Switzerland, Netherlands and Ireland). Since its creation in 2005, our Life sciences division in Belgium is on a continuous growth with more than 140 professional and dynamic consultants. We build up a close management relationship with our consultants by providing them a unique coaching support and specific trainings enabling them to have a fulfilling and exciting consultant career. To further expand the team in The Netherlands we are looking for highly motivated enthusiastic knowledgeable people

Functie-eisen

You are dynamic, ready to challenge yourself on highly demanding projects? In your mind, the client satisfaction comes first and the added-value you bring to your project is one of your top priorities? If you share our values let us guide you toward expertise!

To sustain our growth, we are continuously recruiting engineers and/or academics with a background in Pharmaceutical and Biotechnological Engineering for the following positions:

• Junior consultants with at least a first significant experience to join our project teams;
• Senior Consultants with a sound experience to be involved in team and project management of one or several projects, or to take part as expert in several projects.

An international mobility is preferred and an excellent practice of English is mandatory to join our team.

Bedrijfsprofiel

Altran

Founded in 1982 in France, represents a unique endeavour. 18.000 engineers, consultants and managers at the very heart of the finest advances in technology. Today, we are European’s leading innovative consultancy, providing high value-added support for innovation. As a pioneer in the field of innovation consulting, Altran brings together the whole range of engineering and consulting specialties. We offer our consultants and managers the broadest choice of sectors of intervention on the market: Telecom & Media; Bank, Retail & Government; Electronics; Energy; Life Sciences; Industrial Sectors; Automotive, Railway & Aerospace. At Altran, services cover the entire project cycle, thereby allowing our consultants to combine consulting with implementation. This multi-tasking environment offers a rewarding foundation in high-technology skills. Altran is located in Schiphol-Oost and Eindhoven.

Send Application

We look forward receiving your application, by applying online! If you need more information or you have difficulties with applying online, please contact Ms. Samira Chalh (HR Partner), by email: recruitment@altran.nl

Bron: http://www.intermediair.nl/vacature/117880/Consultant+in+Life+Sciences/49

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