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Safety Surveillance Adviser I
4 weeks ago
Department : Global Safety - Global Business Services (GS-GBS).
Does your motivation come from challenges and working in a dynamic environment? Do you thrive in a working environment where close collaboration with key stakeholders and strategic alignment is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might have the right position for you. Apply now and join a growing team, working in an international environment.
The Position
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 Ownerof 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.
Comfortable user of Microsoft office package (Outlook, Word, Excel, and PowerPoint).
Fluent in written and spoken English.
Analytical mind-set.
Professional authority.
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.
Cross-cultural awareness.
Ability and willingness to quickly adjust to changes in a continuously developing environment.
About the department
Global Safety - Global Business Services (GS-GBS) was set up in 2010 as one of the hub for safety case processing. At GS-GBS, we handle case processing from different sources including spontaneous, literature, solicited and clinical trials. Apart from complete case processing and medical review, GS-GBS is also engaged in safety report submission, training, Learn It administration, quality control of Individual Case Safety Reports (ICSR), Argus configuration and maintenance, information technology quality assurance, signal detection activities, risk mitigation activities, training co-ordination and literature surveillance activities, including medical literature monitoring.
