Director of Safety and Risk Management

Vor 7 Tagen

Munich, Bayern, Deutschland Daiichi Sankyo Europe Vollzeit
Job Title: (Senior) Director Safety Physician - ADC (m/f/x)

About the Role:

We are seeking a highly qualified candidate to fill the position of (Senior) Director Safety Physician - ADC (m/f/x) at Daiichi Sankyo Europe. As a key member of our team, you will be responsible for developing and implementing the global safety strategy and risk management activities for our oncology product portfolio.

Key Responsibilities:

  • Develop and implement the global safety strategy and risk management activities for assigned oncology product portfolio.
  • Collaborate with Global and EU Product Safety Leads and interface with key stakeholders to drive proactive implementation of risk management initiatives.
  • Engage in signal detection/management and safety analysis activities in post-marketing phase.
  • Lead the development, maintenance, and submission of relevant RMPs, PSURs for designated product(s).
  • Oversee the effectiveness of overall risk management activities.
  • Provide medical-scientific support of clinical trials, Post Authorisation Safety Studies (PASS) and non-interventional studies (NIS) concerning pharmacovigilance aspects.
  • Manage regulatory responses to emerging safety issues and provide strategies to address these in collaboration with global safety team.

Requirements:

  • Completed study of human medicines (MD)
  • Work experience (hospital, university, CRO etc.) of at least 5 years
  • Experience in the field of pharmacovigilance of at least 3 years
  • Knowledge of the international legislation as well as the guidelines concerning pharmacovigilance
  • Good or excellent computer skills and good or excellent knowledge of English

Why Work with Us:

At Daiichi Sankyo Europe, we are committed to making a difference in the lives of patients. We foster a culture of mutual respect and continuous learning, with a strong commitment to inclusion and diversity. If you have a proactive mindset and passion for addressing the needs of patients, we eagerly await your application.

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