01Overview
As a Safety Surveillance Adviser, you will be responsible for establishment of the product safety profile during development and maintenance of the labelling for marketed products. Furthermore, perform ongoing and systematic surveillance of Novo Nordisk (NN)products during pre-approval and post-approval phases based on safety information from worldwide sources and communication of drug safety issues internally and to health authorities (HAs), as required. You will be required to establish, operate and chair the NN cross-functional safety committee throughout the lifecycle of the actual product present analysis and results of the ongoing safety surveillance at pre-defined intervals in order for the safety committee to make endorsements/recommendations. You will be responsible for all areas related to patient safety in clinical trials. You are entrusted to fulfil the following responsibilities:
- Act as Owner of the safety sections of the labelling for the evolving Company Core Data Sheet (CCDS) for developments products. Maintenance of labelling for marketed products and participate as labelling change request (LCR) reviewer and provide safety input as LCR reviewer.
- As author you will prepare relevant sections of Development Safety Update Reports (DSURs), periodic Responsible Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs) and clinical Risk Management Plans (RMPs) according to implementation plans or as required by Health Authorities (HAs). Respond to requests from HAs and internally from NN affiliates.
- Provide safety input to Product Development Plan (PDP), Trial Outline, Protocol, Clinical Trial Report, Investigators Brochure (IB),integrated safety summaries, abstracts and planned publications.
- You will provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct Investigator training as required.
- Provide answers to enquiries from HAs and Ethics Commit .
