stillingsbetegnelse: Senior Safety Operations Adviser

jobbeskrivelse:
- Pharmacovigilance - Denmark - Bagsværd Are you interested in making a difference in patient safety for Novo Nordisk? – Then you may be our new Safety Operations Adviser. About the department We are looking for a Senior Safety Operations Adviser to join our Safety Operations (SO) Advisers team from 01 April 2015.You will be part of a team of academic employees with different scientific backgrounds and cultural diversity with 8 nationalities represented. The SO Advisers Department belongs to Safety Operations, one of the functional areas in Global Safety. The core activity of the department is to perform the medical evaluation and impact analysis on patients’ safety of adverse event reports and product quality issues of our product portfolio to ensure compliance with regulatory requirements globally. You can look forward to a position where you can use your medical knowledge and analytical skills.Novo Nordisk has a broad development portfolio in diabetes, endocrinology and haemostasis with several products in the approval phase and new submissions this year. Safety information is assessed already during the development phase of a drug and is maintained after the regulatory approval throughout the whole lifecycle of the product. The Job As a Senior Safety Operations Adviser you will be primarily responsible for the medical interpretation and evaluation of adverse events based on the individual medical case histories reported from our clinical trials and marketed products. It is your job to make sure that the tight timelines for global regulatory safety reporting are met. Moreover, you will analyse the potential impact on patients’ safety of any product quality issues from our product portfolio. You will provide safety input to clinical trial protocols, train and supervise other colleagues on medical evaluation to ensure high quality of data, train monitors and investigators, drive and participate in continuous quality improvement projects. You will be chairing cross-functional teams in clinical trials within Global Safety. You will work in a fast-paced environment reflecting the increasing demands from regulatory authorities while always bearing the patient in mind. Deadlines, cross-functional collaboration, and international communication will be part of your busy workday. Qualifications You have a Master degree in Medicine or Veterinary with excellent knowledge of clinical pharmacology and pathophysiology. Drug safety experience is a must. You are good at communicating, planning and coordinating multiple activities. You have excellent cooperative skills and a high degree of flexibility. As a person you are dynamic, eager to learn new processes, careful with your tasks and have ownership behaviour and a positive attitude to challenges. You must be able to work against tight deadlines, have a good sense of urgency and cope well under pressure still maintaining your good sense of humour. You speak and write English fluently. At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and close to 366 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 about the job please contact Claudia Pierleoni-Nielsen +45 3075 9671. Deadline 29 January 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse:
Andet ingeniørarbejde (undtagen elektroteknologi)

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark