English speaking vacancies in Holland: VACANCY in HOLLAND: Pharmacovigilance Alliance Manager

Tuesday 9 July 2013

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

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Introduction of the ‘European Blue Card’

As from 19 June 2011 the Netherlands has a new purpose of stay: the European Blue Card. The European Blue Card is a separate purpose of stay in addition to the existing National Highly Skilled Migrant Programme. The EU Blue Card Council Directive is intended for highly skilled foreign nationals who do not have EU, EEA or Swiss nationality, and who wish to work in one of the member states of the EU. The Directive is also meant to make it easier to settle in another EU member state. A residence permit will always be required in that other member state, however. To obtain this residence permit the employee must comply with the conditions applicable in that member state.

The conditions for residence in the Netherlands as an EU Blue Card holder are stricter than those for residence as a Highly Skilled Migrant. The employee must have a contract for highly qualified employment for at least one year, earning at least EUR 60,000 gross (in 2011). The employee must have completed a course of higher education lasting at least three years. The employee must prove this by having his diploma assessed by Nuffic. For a regulated profession, a competent authority will take decisions about the admission to that profession.

Advantages
One of the advantages of the EU Blue Card is that it is easier for an EU Blue Card holder and his family members to settle in another EU member state at a later date. After eighteen months foreign nationals who have an EU Blue Card are exempted from the provisional residence permit (MVV) requirement, if they want to work in another EU member State. In this second member state the employee must submit an application for a residence permit as a holder of an EU Blue Card. Each member state may implement the directive in slightly different ways. If someone holds a Blue Card in the Netherlands, this does not mean that the requirements are also met in other member states.

Another advantage is that after having stayed lawfully with the EU Blue Card holder in the Netherlands for two years, the family members may apply for a residence permit for ‘continued residence’. For other purposes of stay this is only possible after having stayed lawfully in the Netherlands for three years. The family members must have resided legally and continuously within the territory of an EU member state for at least five years, however. An employee who has stayed legally in the Netherlands as an EU Blue Card holder for two years may apply for the status of ‘long-term resident as a non-EU member country national’. He must have resided legally and continuously within EU territory for five years and must comply with the other conditions for this purpose of stay.

Highly skilled migrants from outside of the EU

A highly skilled migrant is a migrant who comes to the Netherlands to be employed, and has a gross annual income of at least €47,565, or €34,881 if he/she is under thirty. This income requirement does not apply if the employee enters service for certain functions in an educational or research institution. For information on the specific functions to which this clause applies, you can inquire at the IND office for labour and highly skilled migrants. When a foreign national has been granted residence in the Netherlands as a highly skilled migrant, the employer of the highly skilled migrant is not required to be in possession of a work permit for that foreign national.

Professional soccer players, ministers of religion, teachers of religion and prostitutes are not eligible for a residency as highly skilled migrant.

Important!
The amounts stated above will be indexed every year as of 1 January.