stillingsbetegnelse: Senior Clinical Safety Associate

jobbeskrivelse:
- Pharmacovigilance - Denmark - Bagsværd We are looking for a Senior Clinical Safety Associate to join the Safety Operations (SO) Case Management II department in a permanent position, starting 1st of April 2015. About the department The SO Case Management II department belongs to Safety Operations, one of the functional areas in Global Safety. Global Safety is responsible for the global handling and reporting of adverse events to authorities, and the surveillance of the safety and quality of Novo Nordisk clinical development and marketed products. The department consists of 13 highly engaged colleagues; we are working in a fast-paced environment reflecting the increasing demands from regulatory authorities. Geographically the department is situated in Bagsværd. The job As a Senior Clinical Safety Associate you will be responsible for handling adverse events reported world-wide from Novo Nordisk A/S clinical trials to ensure that global regulatory requirements are met. You should use your medical skills to evaluate individual case stories and it is expected that you can provide guidance to colleagues and relevant stakeholders in all case handling aspects. As a Senior Clinical Safety Associate you should be able to foresee which impact, changes to case handling related processes will have on other interlinked and related processes. The job may involve participation in projects in Global Safety, or in other parts of the organisation, in addition to being responsible for preparing SOPs/working instructions where it is expected that you can act independently as Subject Matter Expert within the case handling field. Deadlines, cross-functional collaboration, and international communication will be part of your workday. Qualifications You have an educational background as a nurse and minimum 3 years of experience within the pharmacovigilance and case handling field. You have in depth knowledge of all case handling processes and are able to explain case handling processes with reference to relevant SOPs, working instructions and regulatory requirements. You are proficient with both written and spoken English. You have flair for using IT systems and you are highly skilled within MS Office, including Excel. As a person you are self-driven, have excellent learning -and analytical skills with a strong ability to communicate, plan and coordinate multiple simultaneous activities. You promote knowledge sharing and focus on ‘win-win’ solutions. You are diligent, show flexibility and are a good team player. We offer an exciting job with lots of challenges among good colleagues in a positive working environment. The application should be written in English. At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference. Contact For further information, please call Trine Vollmond on +45 3079 5711. Deadline 31 January 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark