Improving the health of people worldwide through the provision of innovative and reliable products. Your important contribution to Astellas’ mission? Achieving an optimum risk-benefit for products throughout the lifecycle of the drug. As an expert in pharmaceuticals and risk management you can play a key role across the various global pharmacovigilance functions. 

Director Risk Management Pharmacovigilance
40 hours, Leiden, The Netherlands

Your job as a Director Risk Management Pharmacovigilance

Are you a well-organized, risk management professional with experience in developing global strategies?  Are you able to play a key role in an international organization and contribute to an actively evolving area of risk management as well as benefit risk? Then Astellas has an interesting job opportunity for you.

Your job as a Director Risk Management

As a Director Risk Management you are responsible for the development of risk management activities and the strategies that are aimed at achieving optimum risk-benefit for products throughout the lifecycle of the drug. Through strong leadership, communication and risk management expertise you will be able to successfully advise stakeholders and ensure effective collaboration across the various global pharmacovigilance (GPV) functions. Your main responsibilities are:

• Leading the development of policies for project/product risk management strategies and regulatory action plans for real and theoretical safety risks in partnership with the project/product team;
• Advising product teams to optimize the implementation of risk management strategies;
• Advising teams to lead the development of pre- and post-approval safety commitments;
• Creating and fostering an environment of partnership and collaboration between GPV and the project/product team;
• Developing and sustaining constructive relationships with preclinical disciplines, Medical Affairs and other teams involved;
• Advising teams to ensure risk management awareness, for instance at investigator meetings.

Your personal qualifications as a Director Risk Management Pharmacovigilance

• Advanced related sciences degree (PhD or MD);
• At least 5 years of pharmaceutical/health related industry experience in Drug Safety, Clinical Development or Pharmacovigilance;
• At least 3-4 years of direct experience in risk management;
• Global responsibilities in previous role(s) preferred;
• Excellent knowledge of ICH, US & EU regulations for pharmacovigilance.

Candidates should have strong leadership and organizational skills with the ability to work across cultures and functions. The role requires the ability for strategic thinking with a result-oriented manner of working as well as excellent interpersonal skills.

We offer:

• A challenging and diverse job in an international setting
• Excellent career opportunities
• Inspiring work climate within a complex matrix-organization
• 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.

Astellas

Astellas is a Japanese multinational pharmaceutical company employing over 17,000 people worldwide with global sales exceeding 11 billion 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 950 persons in the Netherlands, in Leiden and Meppel.