Pharmacovigilance Senior Safety System Professional

• Clinical Development and Medical
• Bagsværd

Safety Operations (SO) Submission & Support department is looking for a Senior Safety System Professional for an exciting job with a high degree of individual responsibility in a dynamic atmosphere.

About the department

The SO Submission & Support department is part of the Safety Operations Case Management Department in Safety Operations and is one of the functional areas in Global Safety. The department is situated in Bagsværd and consists of 19 highly engaged team members located in Denmark and India (12 + 7).

The department is responsible for the support, maintenance, development and continuous improvement of the global Argus safety database including system interfaces such as Clinical trial EDC system and case intake systems at affiliate levels.

In addition, the department is also responsible for the worldwide submission of individual case safety reports to the authorities according to the regulatory timelines.

The department works in an informal, fast-paced atmosphere with multiple global stakeholders across Novo Nordisk including safety colleagues from around the world.

The job

In the position as Pharmacovigilance Senior Safety System Professional you will have to use your pharmacovigilance and safety system knowledge to maintain, develop and continuously improve the global Argus safety database. This includes configuration of country specific product licenses, code lists, clinical trials and auto scheduling rules for regulatory reporting, trouble shooting and configuration of XML and Gateways.

A key part of the role will be to participate in both external and internal working groups as well as cross-organisational projects to provide subject matter expertise in relation to the global Argus safety database, related interfaces and case handling processes. As project member you will also be performing informal and formal testing, updating standard operating procedures or guidelines and participating in end-user training.

You will also be involved in analysing changes in the pharmacovigilance requirements from regulatory authorities, performing impact assessments and gap analysis towards the Argus Safety database and the related business processes and interfaces.

You will be working in a dynamic department where flexibility on tasks is required.

Together with your colleagues, you will be supporting end-users on a daily basis. This entails front-end trouble shooting, incident reporting and identification of improvement initiatives.

Qualifications

You have a relevant university degree e.g. in natural science or computer science and have been working within the field of pharmacovigilance whereby you have gained an extensive knowledge of pharmacovigilance requirements of post-marketing as well as clinical trial cases. In addition, you have experience in analysing and optimising business processes.

You have a strong experience working with safety databases such as Argus, ArisG or similar from a configuration perspective and have a good understanding of SQL and technical specifications related to interfaces, Gateways, XMLs, DTDs etc. Likewise, you have experience with IT system risk assessment, testing, validation, implementation and maintenance of IT systems.

You have solid experience working in large cross-organisational projects as subject matter expert and related stakeholder management.

The role requires strong analytical skills including the ability to focus on details and adherence to standards while maintaining a balanced business perspective. The capability to understand and connect regulatory requirements, business processes and functionality of IT systems is essential.

You are pro-active and able to communicate complex problems and potential solutions in a clear way taking into considerations business and compliance impact.

You set direction and can handle complex tasks with few or no defined procedures in place. You show commitment, initiative and flexibility and have a good sense of humour. You are open-minded and enthusiastic, a strong team player who can take responsibility and finalise assigned tasks. You are fluent in both written and spoken English on a professional level and feel comfortable working with colleagues from different cultural backgrounds.

Working at Novo Nordisk

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.

The application should be written in English.

Contact

For further information please contact Søren Nilaus Præstegaard at +45 3079 4589.

Deadline

17 November 2019.

Millions rely on us
To work for Novo Nordisk you will need the skills, dedication and ambition to change lives for the better for millions of patients living with diabetes and other chronical diseases. In exchange, we offer the chance to be part of a truly global workplace, where passion and engagement are met with opportunities for professional and personal development.