Experienced Safety Surveillance Adviser, Global Safety

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Ballerup

Do you want to work with drug safety in clinical development?

Do you want to play a key role in developing new innovative and safe products within medical dermatology? And would you like to be part of the LEO Pharma journey to become the world’s preferred dermatology care partner? Then you may be our new colleague in Safety Surveillance.

The Position

Safety Surveillance is a department within Global Safety (GS) responsible for surveillance of all safety information for LEO Pharma’s products that are marketed or under development.

We are looking for an experienced Safety Surveillance Adviser (Principal Safety Surveillance Professional), who can support our products in clinical development stage II/III and act as GS lead.

It will be your job to:

  • Contribute to development of clinical trial protocols and clinical trial reports
  • Represent Global Safety in clinical cross-functional teams
  • Perform critical analysis and medical evaluation of the emerging aggregate safety data and contribute to establishment of the product safety profile during development and early post-marketing stages
  • Contribute to the development and review of regulatory submission documents for global marketing authorization applications and labelling discussions
  • Perform medical assessment and medical review of ICSR
  • Participate in preparation of communication about the benefit risk assessment (e.g., via Development Safety Update Reports and Risk Management Plans)
  • Build and maintain drug safety expertise, understanding international safety regulations and guidelines

You will get the opportunity both to work independently and in collaboration with a team of highly skilled, committed, and enthusiastic colleagues. Assuming responsibility, communicating information and acting will be essential parts of your workday.

You will collaborate with a team of leading safety specialists who are ready to support you and you will have a close collaboration and interaction with other functional areas such as non-clinical, clinical operations, medical department, and regulatory affairs.

Qualifications

Preferable you have a Medical Doctor (MD) degree. You have a minimum of 6 years of experience in the pharmaceutical industry. Experience with clinical development from drug safety perspective is a requirement. A solid understanding of medical concepts, disease processes, scientific methodology, drug development and data analysis is especially important, and documented scientific training or experience from interactions with regulatory authorities will be an additional advantage.
As a person you are a strong collaborator and a dedicated team player who thrives in an environment of continuous development. You are responsible, well-organized, a strong communicator and able to work under pressure when.

You are fluent in English both written and spoken (company language) and an experienced user of MS Office.

Working at LEO Pharma

We are a dedicated and ambitious team. Global Safety Surveillance consists of 30+ dynamic colleagues striving to safeguard our patients and to improve the quality of our processes and developing our competencies to meet the need of the patients and other stakeholders, internally as well as externally. We are driven by a high level of integrity, science, passion for our work and an open-minded approach.

The position is placed in the LEO Pharma headquarters in Ballerup.

Contact

For further information about this exciting opportunity please contact Alice Bjerregaard Larsen, +45 42282308.

Deadline

Please apply for the positions no later than 14th November 2021. We will review the applications on an ongoing basis, so we encourage you to apply as soon as possible.


Information og data

Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".

Arbejdsstedet er beliggende i Ballerup.

Jobbet er oprettet på vores service den 28.10.2021, men kan have været deaktiveret og genaktiveret igen.

Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
  • Øvrige
  • Ballerup
  • Søndag den 14. november 2021

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