Senior Safety Operations Adviser in Global Safety - Denmark
- Are you interested in making a difference in patient safety for our company?
- Then you may be our new Senior Safety Operations Adviser.
About the department
- We are looking for a Senior Safety Operations Adviser to join our Safety Operations (SO) Advisers.
- You will be part of a team of academic employees with different scientific backgrounds and cultural diversity.
- 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.
- Our company 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 life-cycle of the product.
- As a Senior Safety Operations Adviser you will be responsible for the medical interpretation and evaluation of adverse events based on individual medical cases reported globally from clinical trials and marketed products. It is your job to make sure that the tight timelines for global regulatory safety reporting are met.
- Furthermore, you will provide safety input to clinical trial protocols & related documents, chair or participate in clinical trial meetings within Headquarter and train monitors & investigators globally with regards to safety reporting.
- The position also holds responsibility to medically evaluate the potential risk to patients in relation to product quality issues, train & supervise colleagues on medical evaluation to ensure high quality of data as well as take part in continuous quality improvement projects.
- 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 workday.
- You have a Master degree in medicine or health science with profound knowledge of clinical pharmacology and pathophysiology.
- Drug safety experience is an advantage.
- 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 behavior 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.
Working with Us:
- We are an organisation with many international employees and we welcome local as well as non-local applicants.
- We offer an inspiring and ambitious working environment, alongside the flexibility that allows you to influence your own working day.
- We believe that is what stimulates the ingenuity to develop the next generations of cutting-edge treatments.
- Your skills, dedication and ambition help us change lives for the better.
- In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development.