stillingsbetegnelse: Safety Surveillance Publisher

jobbeskrivelse:
- Pharmacovigilance - Denmark - Bagsværd Do you thrive in a dynamic, international environment with multiple tasks and tight deadlines? Are you detail orientated, and do you have an IT mind-set with focus on structure and quality? Then you may be our new Safety Publisher. About the department Safety Surveillance Reporting is responsible for preparing regulatory reports and related documentation reporting on surveillance of adverse reactions for marketed products and products under development at Novo Nordisk A/S. We are a dynamic, well-functioning, international team of 10 Safety Medical Writers, 6 Safety Publishers and 6 Safety Data Analysts. We work closely with other functional areas across Novo Nordisk (incl. Global Safety, Regulatory Affairs, and Clinical Development) to coordinate and prepare high quality key safety documents submitted to health authorities. As we work in a rapidly changing regulatory landscape, where global requirements for reporting on pharmacovigilance activities are still evolving, change-readiness and out-of-the-box thinking are invaluable assets. The job Key safety reporting documents (Development Safety Update Reports, Periodic Safety Update Reports, and Clinical Risk Management Plans) must be submitted to regulatory authorities in high quality and easily navigable electronic format in accordance with current external and internal guidelines. As a Safety Publisher you will be responsible for archiving and compiling documents, structuring and publishing compiled documents in electronic format using the Novo Nordisk document management system, novoDOCS (based on DOCUMENTUM), and Insight Publisher. Using IT tools such as Adobe Acrobat and Toolbox will be part of your daily work. You will also be responsible for performing electronic format QC of documents and English language QC (in accordance with writing style guides). In addition, the Safety Publisher coordinates the collection and maintenance of organisational benchmark data and KPI’s, and manages the periodic reporting processes. Continuous optimisation of the existing business processes is an integral part of the job. Qualifications The Safety Publisher must hold a master’s degree preferably within English, information sciences, communications, or a comparable discipline. Applicants should have excellent English writing skills and full proficiency in MS Office package. Experience within one or more of the following fields is highly desirable: electronic publishing, document management systems, content management systems (especially SharePoint) and citation management systems (e.g. EndNote). The Safety Publisher position requires good planning/coordination skills and a strong quality mind-set with attention to details. You must be able to maintain a broad overview while juggling diverse tasks; have a systematic and structured approach to solving tasks, be flexible in your approach to your work, and be able to accommodate tight deadlines. Project management experience is an advantage. Pro-active thinking, accountability, and willingness to continuously developing personal and technical skills are important assets. In a day-to-day setting, you are acknowledged as a team-player with good spirit and a can-do attitude. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Anders Reinholdt Thunell at +45 3075 2746. Deadline 11 September 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark