Senior Clinical Safety Associate in R&D - Denmark
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Posted on : 20 March 2017
We are looking for 2 Senior Clinical Safety Associates to join the Safety Operations (SO) Case Management teams in permanent positions.
About the department
- The Safety Operations Case Management teams are part of the Safety Operations Case Management Department in Safety Operations and is thereby 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 company clinical development and marketed products.
- The 2 Case Management teams each consists of 15 highly engaged colleagues; we are working in a fast-paced environment reflecting the increasing demands from regulatory authorities.
- As a Senior Clinical Safety Associate you will be responsible for handling adverse events reported world-wide from company clinical trials to ensure that global regulatory requirements are met.
- You should use your medical skills to evaluate and process 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 standard operating procedure (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.
- 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 Standard Operating Procedure (SOPs), working instructions and regulatory requirements.
- You are proficient within 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 work in a structured manner with a sense for details.
- 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.
Working with Us:
- We strive for excellence.
- As a world leader in diabetes care and a major player in haemostasis management, growth hormone therapy and hormone replacement therapy,
- We offer our employees opportunities for continuous growth.