Senior Clinical Safety Professional (Denmark, Søborg)

Jobbeskrivelse
Placering
Søborg, Denmark

Jobkategori
Reg Affairs & Safety Pharmacovigilance

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Do you want to contribute to the safety and quality of Novo Nordisk clinical development? Do you have the strong pharmacovigilance experience it takes to execute and supervise on 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 Senior Clinical Safety Professional we are looking for.

Read more and apply today for a life-changing career!

The position
As a Senior Clinical Safety professional, you will be responsible for handling adverse events reported world-wide from Novo Nordisk 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:

• Anticipating the impact of changes to case handling processes on interconnected and related processes.
• Contributing to the updates of standard operating procedures (SOPs)/working instructions demonstrating independent Subject Matter Expert expertise within the field of case handling.
• Participation in projects in Global Patient Safety, e.g., contribute to the oversight, support and coordination of outsourcing activities to CRO and ensuring integrations of new molecules in Safety Operations processes.
• Involvement in presentation of Safety Operations processes at inspections and audits.
• Managing dedicated clinical trials, serving as the primary contact from case handling team for relevant stakeholders on larger clinical trials concerning specific safety issues.
• 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.

Your daily responsibilities will include managing deadlines, engaging in cross-functional collaboration, and participating in international communication. Assuming responsibility, communicating information, and taking action will be essential parts of your workday.

Our commitment to innovation also applies to the way we work. We therefore embrace the hybrid workplace – with a blend of home office in Denmark and on-site work in Soeborg where our team is based.

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 strong experience and understanding of processes and regulatory requirements within pharmacovigilance, and clinical trial regulation.
• Documented extensive hands-on experience within safety case handling.
• Strong understanding of clinical trial and project management processes.

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 Patient Safety. Global Patient 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 Novo Nordisk
Novo Nordisk 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. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees. Together, we go further.

Contact
For more information, please contact Marie Werngreen at +45 3077 5176, Stine Bastian at +45 3079 5470 or Martin Duus Holle at +45 3444 7452.

Deadline
8 December 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 Novo Nordisk 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.