Novo Nordisk is a global healthcare company with 89 years of innovation and leadership in diabetes care. The company also has leading positions within Haemophilia care, growth hormone therapy and hormone replacement therapy. Headquartered in Denmark, Novo Nordisk employs approximately 33,300 employees in 75 countries, and markets its products in more than 190 countries Novo Nordisk’s B shares are listed on NASDAQ OMX Copenhagen (Novo-B).
Post: Team Lead I - Case Management
Job Description
You will become a member of the safety team which is responsible for processing of ICSRs. 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.
- 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 whether the product is in clinical development or
- Primary driver of process optimisation of the operational case handling
- Contribute to the build-up of a strong team, which can work professionally in the operational handling of adverse events in close collaboration with affiliates and other partners.
- Maintain a network of safety contacts within safety operations and affiliates.
- Conduct performance management, individual development plans, job descriptions and performance evaluation.
- Ensure continuous development of employees, training/coaching in pharmacovigilance and in departmental functions as well as provision of knowledge about NN business.
- To negotiate processes for collaboration with Contract Research Organisations regarding SAE reporting and establish excellent working relationships with these.
- To participate in the development and maintenance of departmental and functional procedures which have to ensure the observance of internal and external requirements for the management of safety information
- To supervise the daily activity of the team, including vacation, planning and other activities.
- Monitor and ensure that KPIs for evaluation and reporting of adverse events are maintained.
- To have extensive knowledge of Novo Nordisk safety database (Argus).
- Close co-operation with other groups in Global Safety. Liaise with the Safety Reporting and IT in all aspects of E2B reporting; database and application management; data retrieval; custom reporting.
- Measure and present internal and regulatory compliance.
- Maintenance of MOMs related to case processing and QC feedbacks.
- Responsible for providing inputs for updates of SOPs
- Provide input to safety data exchange agreements and pharmacovigilance system description documents regarding the post marketing surveillance process.
- Conduct safety trainings for new pharmacovigilance staff and other company units.
- Establish and maintain a thorough understanding of safety requirements of the project protocol, and safety reporting workflow, set up and maintain project materials such as project files, forms, templates, databases and workflow.
- Establish and maintain effective project communications by representing department at interdepartmental project team meetings to understand and adhere to specific safety reporting requirement.
- The tasks demand self-dependence and competence in making decisions, as well as flexibility, a good comprehensive view and a many-functioned, often international, co-operation.
Candidate Profile
Bachelor/Master in life science (Health care professional)
Working knowledge of MS Windows applications including MS Office tools, good written and spoken English, extensive knowledge of medicinal terminology and clinical pharmacology
Knowledge of basic and advanced GCP (Good Clinical Practice) & GMP (Good Manufacturing Practice) Self-motivated and proactive, Quick learning and analytical skills, ability to motivate and engage individuals, ability to take up initiatives.
Additional Information:
Location: Bangalore
Education: Bachelor/Master in life science (Health care professional)
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Pharmacovigilance
End Date: 31st October, 2014
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