Beskrivelse: We are looking for a Drug Sa...

Beskrivelse:
We are looking for a Drug Safety Analyst within the department of Drug Safety Surveillance (DDS).
International Drug Safety (IDS) is responsible for the surveillance and risk management of all Nycomed's pharmaceutical products whether marketed or in clinical development. We work closely together with Medical, Regulatory, Production and Quality in both headquarters and Local Operating Companies (LOCs). IDS is located at two sites: Konstanz, Germany and Roskilde. We are currently 60 employees of whom 32 are located in Konstanz, 26 in Roskilde and 2 in the US.
DSS is one of five departments in IDS and presently staffed with 15 people. We are overall responsible for surveillance of marketed products. You will be member of a group with 4 colleagues, all located in Roskilde.
ChallengesAs Drug Safety Analyst you will among other things be involved in:

Handling of Individual Case Safety Reports including assessment and medical evaluation
Handling of safety requests from partners, IDS groups and Nycomed departments
Support to LOCs in Pharmacovigilance tasks
Safety Management Teams
Signal detection
Reconciliation of data with CROs, partners, production and LOCs Preparation of guidelines and Standard Operation Procedures
Regulatory reports (e.g. PSUR, Annual Safety Reports)
Handling of safety information through search and collation of data
Validation of safety database and agreements with partners
Safety in clinical trials

We offer As Drug Safety Analyst you can look forward to:

An interesting job working in a true international, cross-disciplinary environment 
Dedicated and humorous colleagues who uphold a good working environment
Education through participation in seminars, congresses and "on the job" training
Flexible working conditions and influence on the job content 
Salary according to qualifications
8 – 10 travelling days yearly might be expected

QualificationsOur preferred candidate has the following professional and personal qualifications:

Nurse, pharmaconomist or similar
Pharmacovigilance experience is preferred, but not absolutely required
Wide clinical knowledge
Possess good communicative skills in English, both written and spoken
Have a well-structured approach to the tasks, a sense for details and high level of responsibility
Excellent cooperation skills

For more information, please contact Senior Group Leader, Mette Rynkebjerg at +******or +******, or Drug Safety Analyst Jens Molbech Odgaard at +******. Please be aware of vacation until 4 August 2009. Job interview and test are planned for week 34 and 35.