Astellas Pharma
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Leiden (The Hague Area, Netherlands)
Job Description
Pharmacovigilance Alliance ManagerLocation: 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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