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Job Details

Senior Manager PVQA - Leiden, The Netherlands

Company: Astellas Pharma Europe B.V.
Location: Leiden, Netherlands
Reference: 121101
Closing Date: 18 Dec 16
Type: Full Time
Salary (£): Competitive
Benefits: Excellent, comprehensive and flexible

Job Summary:

Would you like to be part of a young, growing and forward thinking team? Would you like to play a key role within our Pharmacovigilance Quality Assurance organization and be responsible for determining meaningful changes? Then Astellas has an interesting job opportunity for you!

Requirements:

Senior Manager PVQA
Fulltime, 40 hours, Leiden, The Netherlands

 

Your job as a Senior Manager PVQA
In this position you are responsible for the full oversight and conduct of audits in support of the Pharmacovigilance annual audit schedule. Audits include but are not limited to internal systems, affiliates, vendors and partners. You also review the corrective and preventative actions (CAPAs) proposed for appropriateness and follow up that they are finalized accordingly. Next to that you support the preparation, hosting and responses to the regulatory agency for Pharmacovigilance inspections and third parties audits. Furthermore you provide advice and guidance on regulatory requirements and SOPs interpretations.

Your personal qualifications as a Senior Manager PVQA

  • Master’s degree in pharma or life sciences
  • At least 5 years’ experience in Pharmaceutical research, including Quality Assurance/GCP auditing (especially in Pharmacovigilance audits)
  • Experience in conducting audits on a global basis
  • Knowledge and/or awareness of applicable regulations and guidance related to global and regional/local Pharmacovigilance requirements
  • Experience in the Drug Safety field is preferred


As a Senior Manager PVQA you have excellent project management skills and the ability to influence without authority. Furthermore you have very good interpersonal and communication skills. You also have attention to details and you are flexible and able to adapt.

We offer

  • A challenging and diversified job in an international setting
  • Good career opportunities
  • Inspiring work climate
  • Attractive remuneration, which includes: a 13th month, excellent pension policy, health insurance compensation, collective health insurance, company own saving scheme arrangement, 25 Holidays + 13 so called ADV Days and more…


At Astellas, we believe that nurturing a good relationship with our employees delivers good business results.
It is our stated aim in the VISION for Astellas to be recognised as an Employer of Choice. This means ensuring we are a highly effective organisation, that applies best-in-class people management, creates a positive working environment and has an inspirational company culture.. This reflects the working culture of Astellas, outlines our expectations as an employer and captures the essence of our company ethos; CHANGING TOMORROW.

About Astellas
Astellas is a Japanese multinational pharmaceutical company employing over 18,000 people worldwide with global sales exceeding 10billion euro. The group’s EMEA headquarters are based in London, with affiliates throughout Europe engaged in research & development (R&D), manufacturing and sales & marketing. With over 4,500 employees, EMEA is an important and growing Astellas region, having key strengths in the therapy areas of Urology, Transplantation, Anti Infectives, Pain Management and Oncology. The global annual R&D investment of 15% to 20% of sales is evidence of the group’s commitment to improving the health of people worldwide through the provision of innovative and reliable products.
Astellas employs around 900 persons in the Netherlands, in Leiden and Meppel.

Mirai House, located in Leiden Bio Science Park, is home to a number of divisions, including the European R&D organization focusing on the development of medicines in the areas of Urology, Nephrology, Pain, and Diabetes/Metabolic diseases. It is the location where the majority of offices and clean rooms and labs are located.

Interested? Please apply via the ‘Apply’ button.

Agency or sales calls are not appreciated

Keywords: Vacancy, Fulltime, Leiden, Senior Manager, Audit manager

Apply for this job: Senior Manager PVQA - Leiden, The Netherlands

Contact Information:

Address:  Astellas NL
Sylviusweg 62 2333 BE Leiden

Netherlands

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