Clinical Safety Professional

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Søborg

Do you want to contribute to the safety and quality of Novo Nordisk’s clinical development? Do you have the pharmacovigilance experience it takes to execute and supervise the handling of adverse events reported from clinical trials? Would you enjoy being a key player in making sure that global regulatory requirements are met? If yes, you might be the Clinical Safety Professional we are looking for. Read more and apply today for a life-changing career! The position As a Clinical Safety professional, you will be responsible for handling adverse events reported worldwide from [xxxxx] clinical trials to ensure that global regulatory requirements are met. You should use your medical background to evaluate and process individual case safety reports and it is expected that you can provide guidance to colleagues and relevant stakeholders in all case handling aspects. Your main responsibilities will be focused on:
  • Foreseeing which impact, changes to case handling related processes will have on other interlinked and related processes

  • Participation in projects in Global Safety, or involvement in updates of standard operating procedures (SOPs)/working instructions where it is expected that you can act independently as Subject Matter Expert within the case handling field

  • Dedicated clinical trials, where you will be main contact from case handling team to relevant stakeholders on larger clinical trials regarding specific safety issues

  • Deadlines, cross-functional collaboration, and international communication will be part of your workday

  • Involvement in the trial initiation phase for all types of clinical trials, where you will ensure trial set-up that supports case handling activities, and you will act as mentor for colleagues on these trials. Moreover, you will be part of our case management trial initiation group/forum

    • Qualifications: We are looking for a candidate who has the following qualifications:
  • B.Sc. degree and/or M.Sc. degree, registered nurse or equivalent within health science

  • Documented +4 years-experience within pharmacovigilance and case handling.

  • Preferably you have experience from a wide range of case handling related activities e.g. training responsibilities, subject matter expert experience or pharmacovigilance audit/inspection experience

  • Extensive knowledge of pharmacovigilance principles as well as clinical trial regulations and regulatory requirements

  • Experience with clinical trial and project management processes

  • Familiarity with [xxxxx] products is an advantage

  • As a person you are self-driven, have excellent learning and analytical skills with a strong ability to communicate (professional proficiency in English), plan and coordinate multiple simultaneous activities. You work in a structured manner with a sense for details. You promote knowledge sharing and focus on ‘win-win’ solutions. You are diligent, show flexibility and are a good team player.

    • About the department Safety Operations Case Management Department is a part of Safety Operations and one of the functional areas in Global Safety. Global Safety is responsible for meeting global regulatory requirements for handling and reporting of adverse events and for the surveillance of safety and quality of Novo Nordisk clinical development and marketed products. We have three Case Management teams each consisting of 15 highly engaged colleagues. Working at [xxxxx] [xxxxx] is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. [xxxxx] relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further. Together, we’re life changing. Contact For more information, please contact Marie Werngreen at +[xxxxx], Stine Bastian at +[xxxxx]or Martin Duus Holle at +[xxxxx]. Deadline 1 September 2024. Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.    You do not need to attach a cover letter to your application, but please include a few sentences on your motivation for applying in your resume or CV. To ensure an efficient and fair recruitment process, please refrain from adding a photo to your CV.  We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At [xxxxx] we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.


    Information og data

    Denne ledige stilling har jobtypen "Apoteker", og befinder sig i kategorien "Sundhed og forskning".

    Arbejdsstedet er beliggende i Søborg.

    Jobbet er oprettet på vores service den 23.8.2024, men kan have været deaktiveret og genaktiveret igen.

    Rapportér
    Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
    • 23.08.2024
    • Apoteker
    • Søborg
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