Aggregate Safety Assessment Manager
Astellas Pharma Europe B.V.
Leiden (Nederland)
3 dagen geleden

Who we're looking for

We are looking for a candidate with a postgraduate Science or Medical degree (PhD., Pharm.D, MD). You have at least 5 years of experience in the health science-related industry with direct exposure to clinical, regulatory or pharmacovigilance functions, including :

  • 1 year of pharmacovigilance experience (advanced pharmacovigilance functions from development and post-authorisation);
  • Significant and demonstrable working knowledge of global pharmacovigilance regulations and guidelines, including US, ICH and EU regulations.
  • Skills and competencies :

  • Demonstrate effective leadership skills including ability to lead a multidisciplinary team within a matrix environment;
  • Working pharmacovigilance knowledge of therapeutic areas in which Astellas operates;
  • Experience with responsibilities for products / safety projects;
  • Excellent communications skills (fluent in English, spoken and written); global mindset;
  • Able to lead meetings, present orally and interact with external bodies;
  • Able to work effectively and influence across cultures and functions;
  • Proven problem-solving skills and able to work independently;
  • Able to manage multiple projects simultaneously and excellent time management skills;
  • Astute observational and analytical skills with a sense of urgency;
  • Accuracy and attention to detail;
  • Creative and innovative thinking;
  • Able to maintain composure in stressful / adverse situations;
  • Able to contribute to strategic decision-making and high-level thinking;
  • Results oriented and ability to deliver high-level quality documents.
  • Company profile

    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.

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