Associate Safety Operations Adviser

3 weeks ago

Bengaluru, India Novo Nordisk Full time

**Associate Safety Operations Advisor.**

**Department - GS GBS SOA, EA & SS and QPPV support.**

**Location - Bengaluru, India.**

**About the Department**

Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed Products and is responsible for global handling and reporting of adverse events reports.

**The Position**

All tasks in the GS-GBS SO Safety Operations Advisers department demand a large professional insight, self-dependence, and competence in making decisions, as well as flexibility, a good comprehensive view and a many-functioned, often international, co-operation. Ensure the fulfilment of global regulatory requirements to the collection, evaluation and reporting of safety information on Novo Nordisk (NN) pharmaceutical products i.e., spontaneously reported adverse events, serious adverse events (SAEs) from clinical trials, investigator sponsored trials, named patient supplies and third-party trials, ensure appropriate medical interpretation and evaluation of adverse events reported from world-wide sources, from marketed use

To contribute to the collection, medical evaluation, and reporting (to the authorities) concerning adverse events from clinical use of Novo Nordisk’s preparations and products in the post approval phase. The tasks demand a large professional insight, self-dependence and competence in making decisions, as well as flexibility, a good comprehensive view and a many-functioned, often international, co-operation.

To be responsible for immediate reporting to the relevant authorities of serious adverse events that may be associated with Novo Nordisk’s products. Omission or a delay to do so can result in serious consequences for Novo Nordisk.

To be responsible for the medical evaluation of reports concerning serious adverse events, as well as for the evaluation of possible causal relationships.
- To ensure the review and preparation of relevant follow up questions, consistency in handling clinical and post-marketing cases. To escalate critical adverse events/reactions to line manager and/or Safety Surveillance Adviser. Medical evaluation and medical review on all case types, as applicable. To review AE, pregnancy, and safety information forms (both electronic forms and paper forms). Monthly review of spontaneous non -serious cases as non-cases as non-serious line listings to ensure consistency in coding and listedness.
- To participate in clinical project groups as well as safety meetings as needed and to ensure responsible coverage of safety areas. To review clinical protocols to ensure that all relevant safety information is captured through the procedures described in the protocol and to ensure that these procedures are in alignment with the workflow in Safety Operations. Point of contact providing support for Data Management colleagues if/when product queries arise.
- To ensure accurate and consistent coding using MedDRA of all adverse events reported NN to ensure consistency and precision between projects, products and countries in the coding of adverse events. To ensure the review and preparation of relevant follow up questions.
- To participate in the GS MedDRA Coding Group and Case Handling meetings as required. To ensure up-to-date knowledge through participation in relevant courses and meetings and through reading relevant literature, regulatory guidelines and new media. To supervise reconciliation process of SAEs with the clinical trial data base. Ensure all tasks are performed in compliance to and in accordance with Good Clinical Practice (GCP)/Good Manufacturing Practice (GMP) requirements.

**Qualifications**
- Post graduate MD / MBBS with relevant Pharmacovigilance experience preferable.
- Documented scientific experience, preferably from the pharmaceutical industry (0 to 1 plus years of experience.
- Good knowledge of diseases, their clinical manifestations, treatment and complications.
- Good knowledge of clinical pharmacology.
- Good knowledge of computers and databases.
- Fluent English, both written and spoken. Accountable, good planning and coordination skills.
- Take initiative, systematic and organised, thorough and analytical.
- Work independently in a team and manage projects.
- Flexibility and good communication skills are necessary in the cooperation with other functions and departments in Global Safety, Global Development, NN affiliates and external collaborators.
- Good understanding and knowledge of PV, clinical development and regulatory requirements are prerequisites for performing the tasks and for providing expert advice to internal and external stakeholders.

**Working at Novo Nordisk**

We are a proud life-science company, and life is our reason to exist. We’re inspired by life in all its forms and shapes, ups and downs, opportunities, and challenges. For employees at Novo Nordisk, life means many things - from the building blocks of life that form the bas

  • Associate Safety Operations Adviser

    1 month ago

    Bengaluru, India Novo Nordisk Full time

    **Department**: Global Safety. **About the Department** Global Safety, Bangalore has global responsibility for surveillance of Safety and Quality of Novo Nordisk clinical development and marketed Products and is responsible for global handling and reporting of adverse events reports. **The Position** All tasks in the GS-GBS SO Safety Operations Advisers...

  • Associate Safety Operations Adviser

    2 weeks ago

    Bengaluru, India Novo Nordisk AS Full time

    Department :  Global Safety. 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...

  • Associate Safety Operations Adviser

    2 weeks ago

    Bengaluru, India Novo Nordisk Full time

       Department : Global Safety. 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...

  • Safety Supervisor

    4 weeks ago

    Bengaluru, India Traditional Steps Associate Full time

    **Responsibilities Of Safety Supervisors** - Are responsible and accountable for their team’s health and safety performance; - Conduct informal health and safety meetings with their employees at least monthly; - Enforce all safe systems of work procedures that the Departmental Manager has issued; - Report to the Departmental Manager any weaknesses in the...

  • Drug Safety Associate

    2 months ago

    Bengaluru, India Bitwise Solutions Full time

    Drug Safety Associate Job Duties Drug safety associates responsibilities include: - Reviewing adverse event reports, safety data sheets, and physician advisories to identify potential risks associated with a particular drug - Conducting site visits to observe the distribution process to ensure compliance with federal regulations - Monitoring compliance...

  • Student Advising Associate

    1 month ago

    Bengaluru, India Springboard Full time

    Bengaluru, India /- University Partnerships - University Partnerships /- Full-time- / Hybrid**The Company** At Springboard, we’re on a mission to bridge the world’s skills gap, offering transformative online education in data science, UI/UX design, tech sales, cybersecurity, and coding. Our courses may be tech-enabled, but we're ultimately...

  • Drug Safety Associate

    3 days ago

    Bengaluru, India GSS Pharma Pvt.Ltd Full time

    Company Description GSS Pharma Pvt.Ltd is an emerging pharmaceutical company based in Bangalore, India. With a focus on manufacturing and exporting finished formulations, GSS Pharma caters to a diversified pharmaceutical market with over 400 formulations in therapeutic segments, including psychotropic and controlled substances. Committed to delivering...

  • Drug Safety Associate

    3 weeks ago

    Bengaluru, India GSS Pharma Pvt.Ltd Full time

    Company DescriptionGSS Pharma Pvt.Ltd is an emerging pharmaceutical company based in Bangalore, India. With a focus on manufacturing and exporting finished formulations, GSS Pharma caters to a diversified pharmaceutical market with over 400 formulations in therapeutic segments, including psychotropic and controlled substances. Committed to delivering quality...

  • Airline Operational Safety Support

    3 weeks ago

    Bengaluru, India Boeing Full time

    Description Qualifications: Boeing India is seeking a candidate to join the Airline Operational Safety Support (AOSS) team as an AOSS Representative based in Bangalore, India . The primary duties of this position are to interface with commercial airline maintenance and engineering departments and provide consultation on a variety airline...

  • Safety Officer

    1 month ago

    Bengaluru, Karnataka, India buildAhome Full time

    Supporting the development of OHS policies and programs - Advising and instructing on various safety-related topics (noise levels, use of machinery etc.) - Conducting risk assessment and enforcing preventative measures* Identifying hazards, ensuring compliance with legislation, and promoting a culture of health and safety in the workplace. - Identifying...

  • Associate Clinical and Safety Publisher

    1 week ago

    Bengaluru, India Novo Nordisk AS Full time

    Department – Clinical Reporting GBS Are you detail-oriented and experienced in compiling and publishing clinical and safety documents? Are you passionate about ensuring the quality and compliance of regulatory submissions? We are looking for an Associate Clinical Safety Publisher to join our team at Novo Nordisk. If you are ready for a new challenge...

  • Sr. Associate, Trust

    10 minutes ago

    Bengaluru, India ADCI - Karnataka Full time

    Come build the future of entertainment with us. Are you interested in helping shape the future of movies and television? Do you want to help define the next generation of how and what Amazon customers are watching?Prime Video is a premium streaming service that offers customers a vast collection of TV shows and movies - all with the ease of finding what they...

  • Associate Manager

    2 weeks ago

    Bengaluru, India Syngene Full time

    JOB DESCRIPTION Job Title: Associate Manager – Legal and IP Job Location: Bengaluru Reporting to: Manager - Legal Job Grade: 7(i) At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following...

  • Trust & Safety Operations Executive

    4 weeks ago

    Bengaluru, India Apna Full time

    **About Company** Founded in 2019, apna is India’s largest professional networking and jobs platform for >250M members of India’s rising working class. Our mission is to connect people to opportunities and help reduce the skill and employment gap. Having raised $190+ million from marquee investors like Insight Partners, Tiger Global, Lightspeed India,...

  • Trainee Operator

    1 month ago

    Bengaluru, Karnataka, India Neha associate Full time

    Job Title: Production Line Assembler and Quality Inspector **Job Description**: We are seeking a skilled Production Line Assembler and Quality Inspector to join our manufacturing team. In this role, you will be responsible for assembling components to create finished products according to specifications, as well as ensuring the quality of these products...

  • Safety Officer

    4 weeks ago

    Bengaluru, India buildAhome Full time

    **Safety Officer Responsibilities**: - Compile safety programs. - Practice safe working techniques. - Implement and maintain health and safety standards. - Establish a cordial and professional relationship with employees. - Maintain compliance with all safety regulations. - Conduct regular staff meetings to share best practice techniques. - Standardize...

  • Operations Executive

    1 month ago

    Bengaluru, India Quality & Food Safety Consultants Full time

    **Job role**: We are looking for a skilled Executive Assistant who will be able to provide operations support to the Food Safety Works team. An Executive Assistant’s duties will involve supporting the management team in tracking the projects, co-ordinate training, help in invoicing, hiring and also work with the marketing team on the customer outreach...

  • Group Manager, Prime Video Trust

    4 days ago

    Bengaluru, India ADCI - Karnataka Full time

    Prime Video is changing the way people watch movies and TV shows, with millions of titles available on-demand on Kindle, Fire TV, mobile devices, game consoles, Internet-connected TVs, and Blu-ray players. Are you excited about launching content on Prime Video and holding key impact on helping our business scale? We are seeking an innovative and think big...

  • Trust & Safety Operations Executive

    4 weeks ago

    Bengaluru, India Apna Full time

    About CompanyFounded in 2019, apna is India’s largest professional networking and jobs platform for >250M members of India’s rising working class. Our mission is to connect people to opportunities and help reduce the skill and employment gap.We help candidates build their digital professional identities, find the best fit hyperlocal jobs, grow their...

  • Group Manager, Prime Video Trust

    5 days ago

    Bengaluru, India ADCI - Karnataka Full time

    Prime Video is changing the way people watch movies and TV shows, with millions of titles available on-demand on Kindle, Fire TV, mobile devices, game consoles, Internet-connected TVs, and Blu-ray players. Are you excited about launching content on Prime Video and holding key impact on helping our business scale? We are seeking an innovative and think big...