Latest Novo Nordisk Jobs
Latest Novo Nordisk Jobs in Bengaluru, Karnataka, India. Safety Surveillance Adviser Position at Novo Nordisk. Interested Candidates check out the details below and Apply below.
Job Posting: Safety Surveillance Adviser I
Job Company: Novo Nordisk
Location: Bengaluru, Karnataka, India
About the Company
Global Safety Global Business Service (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.
About The Position
As a Safety Surveillance Adviser, you will be responsible for the establishment of the product safety profile during the 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.
Responsibilities:
- Establish and Maintain Labelling: 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.
- Prepare Safety Reports: 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: 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.
- Proactive Safety Communication: Provide proactive safety communication by participation in project/trial groups/teams established, as appropriate and conduct Investigator training as required.
- Safety Aspects in Clinical Trials: 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 English: written and spoken.
- Analytical Mindset: with a professional authority.
- Quality Mindset: well-organized and strive for excellence.
- Proactive 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 to work in an international environment.
- Adaptability: to changes in a continuously developing environment.
