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Safety Surveillance Adviser I

3 - 7 years

0 Lacs

karnataka

Posted:3 days ago| Platform: Shine logo

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Skills Required

microsoft office analytical skills signal management aggregate management icsr english proficiency quality mindset proactive planning strong communication team player crosscultural awareness

Work Mode

On-site

Job Type

Full Time

Job Description

As a Safety Surveillance Adviser within the Global Safety - Global Business Services (GS-GBS) department at Novo Nordisk, your primary responsibility will be to establish the product safety profile during both development and maintenance phases of marketed products. Your duties will include conducting ongoing surveillance of Novo Nordisk products worldwide, communicating drug safety issues internally and to health authorities as needed, and leading the cross-functional safety committee. Additionally, you will be responsible for all aspects related to patient safety in clinical trials. In this role, you will own the safety sections of the labelling for evolving Company Core Data Sheet (CCDS) for development products, participate in labelling change requests, and provide safety input for various reports such as Development Safety Update Reports (DSURs), Serious Unexpected Suspected Adverse Reaction (SUSAR) reports, Periodic Safety Update Reports (PSURs), and Risk Management Plans (RMPs). You will also contribute safety input to various documents like Product Development Plans, Protocols, Clinical Trial Reports, and Investigators Brochures, as well as engage in proactive safety communication within project and trial groups. The ideal candidate for this position should hold a Masters in Medicine/MD post MBBS graduate (preferred) and possess relevant experience in Signal Management, Aggregate Management, and ICSR. Additionally, you should be proficient in Microsoft Office applications, fluent in English (written and spoken), have an analytical mindset, exhibit professional authority, and demonstrate a quality-oriented and organized approach to work. Strong communication skills, proactive planning abilities, flexibility, and a service-oriented mindset are essential qualities for success in this role. Novo Nordisk is a leading global healthcare company dedicated to defeating serious chronic diseases, with a strong focus on diabetes. Working at Novo Nordisk offers the opportunity to be part of a collaborative team that is committed to making a positive impact on millions of patient lives worldwide. As an employee at Novo Nordisk, you will be part of a culture that values diversity, inclusion, and continuous improvement. If you are motivated by challenges, thrive in a dynamic environment, and possess the necessary qualifications and qualities, we encourage you to apply for this position by the deadline of 20th April 2025. Please submit your CV and motivational letter online to be considered for this opportunity. Internal candidates are advised to inform their line Manager before applying. Novo Nordisk is committed to an inclusive recruitment process and equality of opportunity for all job applicants. We aspire to be the best company for the world, and we believe that achieving this goal is only possible with talented employees from diverse backgrounds and cultures. Join us at Novo Nordisk and together, we can go further and be life-changing.,

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Pharmaceutical Manufacturing

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