Opportunity for Fresh B.Pharm/M.Pharm/Masters in Life Sciences as Junior Drug Safety Associate at Novo Nordisk
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: Junior Drug Safety Associate
As a Junior Drug Safety Associate you will be part of a young and dynamic team currently consisting of 93 dedicated employees.
This role involves initial evaluation of spontaneously reported adverse events including reports from post marketing surveillance studies. Archiving of cases in Argus.
Expedited lists: Checking daily expedited list. Ensuring accurateness of the list. Detailing deviations if necessary. Data entry and coding of adverse events of non-serious cases on the basis of individual case histories, correspondence with affiliates and other departments in HQ and various administrative assignments.
To ensure accurate and consistent coding of all events for GCC non-serious cases entered in Argus with the use of MedDRA (Medical Dictionary for Regulatory Activities).
To evaluate causality and listedness in non-serious cases.
To assess the need for follow up information and issue draft follow up requests for non-serious cases. Compliance with drug safety issues in an environment with complicated and frequently changing regulatory requirements and guidelines.
Ability to work within strict timelines. Generating weekly lists of all cases and analysis replies handled by the team.
To be responsible for Periodic Safety Update Report (PSUR) clean up and other case clean-up activities.
Maintenance of MOMs related to case processing and QC feedbacks.
To maintain a network of safety contacts within HQ and affiliates. Assist with related administrative and procedural activities as required or requested. Ensure that all tasks are performed in compliance in accordance to GCP/GMP requirements.
We also expect you to take an active part in the continuous development of the growing department.
Typical knowledge and specific experience with IT, including MS Office (Word, Excel), English correspondence and basic knowledge of medicinal terminology
Personal skills inculdes good written and spoken English, team oriented personality with a high degree of flexibility, systematic and organised, thorough and detail oriented, able to work within strict timelines, familiarity with medical terminology and self motivation and proactive stance at work
Preferably you have an educational background as a B.Pharm/M.Pharm/Masters Degree in Life Sciences background.
For more info, go on Next Page...
PLEASE NOTIFY THAT THIS JOB IS EXPIRED.
FIND LATEST JOBS BY CLICKING LINKS BELOW.