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Oud 20 mei 2019, 10:38
JohnHart JohnHart is offline
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Standaard Astellas is looking to hire an Associate Director Medical Safety (Leiden)

Do you have a pharmaceutical or a life science background and experience in Medical Safety? Then Astellas has an interesting job opportunity for you.

Associate Director Medical Safety
Leiden, full-time

Your job as an Associate Director Medical Safety

As an Associate Director Medical Safety, you provide medical safety leadership and direction concerning the design and successful implementation of medical safety strategies for one or more specific Astellas products. You ensure cross-functional implementation and follow-up with the appropriate stakeholders. The major features of this job are:

• Design of safety surveillance strategies for assigned Astellas drug products, both those in development and marketed products.
• Authoring and reviewing medical-scientific reports, safety analyses and evaluations.
• Ongoing monitoring and assessment of the safety profile of assigned Astellas products.
• Timely identification and communication of emerging safety issues and safety updates.
• Risk management of assigned Astellas products.
• Contribution to periodic and ad hoc safety reports in terms of authoring and review of medical sections, the overall medical-scientific analyses and conclusions.
• Contribution to the improvement of systems, procedures and tools.
• Support in inspection/audit preparation.

Your personal qualifications as an Associate Director Medical Safety

• Bachelor or Master Degree in a scientific, health-related field.
• A minimum of 6-8 years of experience in the Pharmaceutical industry, from which 3-4 years of experience in global PV.
• In-depth understanding of safety regulations for both marketed and investigational products and excellent knowledge of regional and global authority requirements.
• Specific working experience in medical safety functions, including experience in analyzing safety data, executing global signal detection activities, global literature review and authoring periodic safety reports and risk management plans.
• Demonstrated ability to work within a global matrix environment.
• Excellent communication and presentation skills in English (both written and spoken).

As an Associate Director Medical Safety, you have strong communication and interpersonal skills coupled with the ability to work across cultures and functions. International travel can be part of the job.

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