Safety Operations Advisor
About The Department
Pharmacovigilance is an area within Global Safety, responsible for medical review and reporting of adverse events. Global Safety has a long and outstanding track-record in pharmacovigilance. You will join the team of 11 highly skilled safety operations advisers, responsible for medical review. We are located at a state-of-the-art facility in Bangalore.
You will become a member of the safety adviser’s team which is responsible for medical review of Individual Case Safety Reports. You will especially focus on defining and integrating user/stakeholder requirements and safety risk management. You will be given a number of different responsibilities and experience a variety of tasks, working with both internal and external stakeholders. The job will enhance your professional and personal development, providing you with an opportunity to develop skills within specialist expertise and project management.
You hold a degree in Medical Science (MBBS or MD) and are looking to kick-start your career within pharmacovigilance and risk management. 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. You have the ability to analyse and understand complex case reports. You are independent, flexible and result-oriented with a ‘can-do’ attitude. You have a solid academic background and must be able to learn fast, excel at cross-functional collaboration and communicate at all levels. You must be prepared to invest significant personal effort in your work and proactively take ownership of your areas of responsibility. Finally, the strongest candidates have relevant medical review experience of at least two years. Experience in clinical trials is an added advantage. Proficiency in oral and written English is essential. At GS-GSC, we use our skills, dedication and ambition to help people with chronic diseases, and change their lives. You will get the opportunity to take part in this, and in addition enhance your career, benefiting from the possibilities for professional and personal development provided by Novo Nordisk A/S.
Key Responsibilities include
To be responsible for immediate reporting to the relevant authorities of serious adverse events that may be associated with Novo Nordisk’s products.
To be responsible for the medical review of reports concerning serious adverse events, as well as for the evaluation of possible causal relationships.
To ensure the preparation of relevant follow up questions.
To ensure consistency in handling clinical and post-marketing cases.
To escalate critical adverse events/reactions to line manager and/or Safety Surveillance Adviser.
Monthly review of spontaneous non-serious 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 participate in safety meetings as needed and to ensure responsible coverage of safety areas with the support of a safety operations adviser.
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 work flow 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 to NN to ensure consistency and precision between projects, products and countries in the coding of adverse events.
To review processes and give input regarding safety information handling and flow of safety information.
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.
At Novo Nordisk, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development.