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Global Safety Lead
2 months ago
We are seeking a highly skilled Global Safety Lead to join our team at Novo Nordisk. As a key member of our safety team, you will be responsible for developing and implementing safety strategies for our products, ensuring compliance with regulatory requirements and maintaining a high level of patient safety.
Key Responsibilities- Establish and maintain safety profiles for assigned products, including development and update of minimum mandatory safety text (MMST) for informed consent and safety sections of labelling for evolving Company Core Data Sheet (CCDS)
- Perform ongoing and systematic surveillance of accessible data within allocated product area(s), taking initial actions to mitigate risks in case a safety signal or alert is detected or aggravated
- Provide input to preparation of Development Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or as required by Has
- Chairmanship/membership of the NN cross-functional safety committees, including participation as a member of the first safety committee chaired by non-clinical and establishment, operation and chairmanship of the safety committee throughout lifecycle of the actual product
- Responsible for all areas related to patient safety in clinical trials, including acting as member of the trial safety group for dose escalation decisions (phase I trials) and providing safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigator's Brochure (IB), integrated safety summaries, abstracts and planned publications
- MD or PhD or equivalent degree with 8+ years of relevant experience or a life sciences/pharmacy nursing degree with 13+ years' experience in global safety surveillance and/or clinical/drug development
- Excellent verbal and written communication skills
- Strong organizational and demonstrated problem-solving capabilities
- Ability to thrive in a busy environment and maintain a positive attitude under pressure
We are a global healthcare company with a commitment to creating a better world for people with diabetes and other serious chronic conditions. We are dedicated to improving the lives of millions of people worldwide through innovative products and services.
We are an equal opportunity employer and welcome applications from diverse candidates. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
