Safety Surveillance Advisor I

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 Serious 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, Investigator s 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 Committees (ECs) regarding safety aspects of protocols and Patient Information (PI)/ Informed Consent (ICs), establish and ensure deliverables to/from Data Monitoring Committees (DMCs). Qualifications

Masters in Medicine/MD post MBBS graduate is Preferred

Relevant Experience in Signal Management, Aggregate Management, ICSR

Fluent in written and spoken English

Quality mind-set, well-organised and strive for excellence

Pro-active planner to meet agreed deliverables

Strong communicator (verbally and in writing)

Curious and constantly looking for improvement opportunities

Team player with high degree of flexibility and service mindedness

Ability and willingness to quickly adjust to changes in a continuously developing environment

Full time