Job in Novo Nordisk for the post of Safety System Professional

Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).

Post: Safety System Professional

Job Description:
As a Safety System Professional you will be part of a young and dynamic team currently consisting of 93 dedicated employees. Maintain, develop and continuously improve the global safety database Argus to ensure IT system compliance with global drug safety requirements and guidelines, particularly concerning electronic submission of adverse events and other safety information relating to NN products reported from worldwide sources. Secure communication to primary stakeholders regarding incidents and problems identified in the global safety database Argus including interfaces to dominating platforms for adverse event reporting i.e. InForm and EtQ. Support end-users within SO in the use of databases and programmes relevant to Safety Operations including Argus, MedDRA and/or CCGloW. Manage internal small to medium size projects of somewhat complexity to ensure quality and timeliness of project deliverables. Participate in cross-organisational projects to provide subject matter knowledge within own area of expertise.

Qualifications
MSc, MBA or similar graduate degree preferable in a biomedical or computer science discipline
Minimum of 1+ years of experience as Safety System Professional or equivalent experience working with IT systems (including databases and web solutions) preferably covering business configuration, user specification, validation, implementation and maintenance of IT solutions in large organisations.

Experience from working in a project oriented, international matrix organisation. Experience in Pharmacovigilance activities. Experienced user of databases and programmes relevant for own role/function including Argus Safety, MedDRA, InForm and EtQ, E2B understanding, SQL knowledge (added advantage), Knowledge and understanding of relevant GxP requirements applicable for position. Solid knowledge of pharmacovigilance principles and regulatory requirements regarding drug safety

You are diligent and have an eye for detail. You show a high level of flexibility and you have excellent communication and cooperation skills.

We invest a lot in both professional and personal development and have a thorough individualised development plan for each employee. As part of your job you will receive intensive training in Pharmacovigilance.

Additional Information:
Experience: Min. 1 year
Requisition ID: 18670BR
Industry Type: Pharma/ Biotech/Clinical Research
End Date: 10^th Dec, 2013