Associate Safety Operations Adviser

By continuing to use and navigate this website you are agreeing to the use of cookies Accept ClosePress Tab to Move to Skip to Content LinkSearch by KeywordSearch by LocationLoading CategorySelect how often in days to receive an alert xc3 x97Select how often in days to receive an alert Associate Safety Operations AdviserCategory Reg Affairs Safety PharmacovigilanceLocation Bangalore Karnataka INDepartment Global SafetyDoes 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 About the DepartmentGlobal 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 PositionAll 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 li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 1 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props 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 li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 2 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props 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 li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 3 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props 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 li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 4 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props 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 li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 5 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props 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 Qualificationsli 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 1 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props Post graduate MD MBBS with relevant Pharmacovigilance experience preferable li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 2 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props Documented scientific experience preferably from the pharmaceutical industry 0 to 1 plus years of experience li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 3 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props Good knowledge of diseases their clinical manifestations treatment and complications li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 4 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props Good knowledge of clinical pharmacology li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 5 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props Good knowledge of computers and databases li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 6 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props Fluent English both written and spoken Accountable good planning and coordination skills li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 7 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props Take initiative systematic and organised thorough and analytical li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 8 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props Work independently in a team and manage projects li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 9 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props 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 li 335552541 aria-setsize -1 data-aria-level 1 data-aria-posinset 10 data-font Symbol data-leveltext xef x82 xb7 data-list-defn-props 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 NordiskWe 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 basis of ground-breaking scientific research to our rich personal lives that motivate and energise us to perform our best at work Ultimately life is why we re all here - to ensure that people can lead a life independent of chronic disease ContactTo submit your application please upload your CV online click on Apply and follow the instructions Deadline10th November 2024 DisclaimerIt has been brought to our attention that there have recently been instances of fraudulent job offers purporting to be from Novo Nordisk and or its affiliate companies The individuals or organizations sending these false employment offers may pose as a Novo Nordisk recruiter or representative and request personal information purchasing of equipment or funds to further the recruitment process or offer paid trainings Be advised that Novo Nordisk does not extend unsolicited employment offers Furthermore Novo Nordisk does not charge prospective employees with fees or make requests for funding as a part of the recruitment process We commit to an inclusive recruitment process and equality of opportunity for all our job applicants At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives backgrounds and cultures We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees the patients we serve and communities we operate in Together we re life changing