Novo Nordisk A/S
Gladsaxe, 1 stilling
- Management
- Denmark - Bagsværd
Are you ready to assume a managerial role for a team of 10 employees in a recently established area in Global Safety? We expect high performance, drive and the ambition to make your mark on our business. If you find these challenges exciting and inspiring, you may be our new Compliance Director securing high quality maintenance of the Pharmacovigilance System Master File, and other pharmacovigilance compliance standards in Global Safety.
About the department
The job is located in the QPPV Office, a recently established area within Global Safety under Corporate Development. Global Safety is globally responsible for handling of adverse events, monitoring product safety, customer complaints and potential recalls in Novo Nordisk. The primary responsibilities of the Compliance department are to ensure that Global Safety is consistent and meets both external and internal pharmacovigilance requirements, including legal compliance and customer expectations.
The department consists of colleagues with different professional background ensuring support to the Qualified Person for Pharmacovigilance, Global Safety employees and Novo Nordisk stakeholders in headquarters and affiliates. Since our unit is situated in both Bagsværd and India, you will have the opportunity to work with our Indian colleagues. You can expect some travel per year.
The Job
You are accountable for delivering the department strategy and execution of plans, including compliance with regulatory requirements through regulatory surveillance, maintenance of the Pharmacovigilance System Master File and pharmacovigilance agreements, timeliness trending and metrics of individual case safety report submission on an ongoing basis, as well as coordination of audit and inspection-related activities in Global Safety. Strong collaboration with the sister departments in the QPPV Office, and our stakeholders in Global Safety, Affiliates, Regulatory Affairs, and Global Development among others is essential for the role. Liaise with audit functions to ensure the appropriate documentation of audits and Corrective Actions in the PSMF is required.
You will work in a fast-paced environment reflecting the increasing demands from regulatory authorities while always bearing the patient in mind. Deadlines, cross-functional and inclusive collaboration, and international communication will be part of your busy workday. It is your job to set direction and provide guidance for your team, take responsibility for your department’s budget, and implement continuous quality improvement projects. As such, you will influence the future of the new area. Reporting to the VP of the QPPV Office, you are part of her management team.Ensuring safe products and compliance with regulatory requirements is at the heart of Novo Nordisk's business. By being part of developing the QPPV Office you can make your mark on our business.
Qualifications
You have a biomedical or another relevant science degree topped with solid experience in pharmacovigilance. You are an experienced manager able to motivate, develop and empower highly educated and independent people. If you have been employed in a global role with project management and communication experience, it will be an advantage. Moreover, you are enthusiastic, energetic, confident and a strong team player. Evidently, you have a good sense of urgency and cope well under pressure still maintaining your good sense of humour. You have demonstrated strategic planning skills and possess strong communication and presentation abilities. Lastly, you are able to work effectively in a highly matrix team structure and capable of influencing cross-functional working groups.
The application should be written in English.
At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment.
Contact
For further information, please contact Pilar Carrero at +45 3075 7476.
Deadline
30 December 2015.
