Associate Safety Operations Advisor
Novo Nordisk
- Bangalore, Karnataka
- Permanent
- Full-time
- 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.
- 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.