We are looking for an Associate Quality & Training Professional to join our Safety Operations (SO) Quality & Training department for a permanent position starting 01-APR-2012.
The SO Quality & Training department is one of the functional teams in Safety Operations (within Global Safety). Global Safety is responsible for the global handling and reporting of adverse event reports to authorities, and the surveillance of the safety and quality of Novo Nordisk clinical development and marketed products. SO Quality & Training department is responsible for quality, compliance, training activities in Global Safety and as well as for safety reporting training of worldwide affiliates.
You will be part of a team of 13 highly dedicated and competent employees. In our daily work we cooperate with cross-organisational departments in Global Safety as well as worldwide affiliates. Our activities are essential to maintain Novo Nordisk safety compliance and ensure the safety of our patients.
Challenges
As an Associate Quality & Training Professional you will be responsible for;
Performing Quality Check (QC) of clinical and post-marketing Individual Case Safety Reports (ICSR)
Evaluating, analysing and trending of Aggregated QC data of (ICSR)
Presenting analysis results to relevant SO departments and our stakeholders
Identification of training needs based on the analysis results
Correspondence with our affiliates and other departments in Safety Operations regarding quality issues
Pharmacovigilance training
Developing new procedures and updating existing procedures as relevant
Qualifications
You have a Master degree in a biomedical discipline (Pharmacy, Life Sciences, or equivalent). You have experience with data analysis requiring advanced use of IT tools including Microsoft Office package, and an excellent command of written and spoken English. Experience from the pharmaceutical industry is an advantage.
You must be able to work under tight deadlines. You will be part of a team and you must contribute to the team and the department's working climate with good humour and spirits, drive, persistence and high quality standards. You must be able to work in a systematic and structured way, with focus on detail and quality control. You are good at communicating, planning and coordinating multiple activities. You have excellent cooperative skills and a high degree of flexibility. We have a relaxed and informal working climate, which is based upon trust, humour and commitment to colleagues and tasks. We offer an interesting job with an individually tailored training package and flexible working conditions.
The application should be written in English.
Contact
For further information, please contact Gordana Koch at +45 3075 9571 (except week 7)or Lotte Finderup at +45 4443 6847.