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: Manager - 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.
Establish, maintain and develop efficient processes for safety case handling in Global Safety – Global Service Centre (GS-GSC) in close collaboration with departments in Denmark in order to ensure compliance with regulatory requirements
Ensure good collaboration between GS GSC teams and Denmark teams
Daily management and development of direct reports, including 3P meetings, development plan discussions and preparation of job descriptions
Act as coach, mentor and/or trainer for direct reports in relation to case handling issues and employee development
Contribute to the planning of and follow-up on the budget for GS-GSC
Ensure timely completion of tasks in accordance with project milestones and with respect to the overall Novo Nordisk prioritisation
Present proposals for initial salary, annual salary adjustments, bonus allocations, and promotions to the VP of GS-GSC
Recruit and lay-off staff in cooperation with the VP of GS-GSC
Plan and contribute to department meetings and the general information flow in the department
Participate in GS-GSC management meetings, raise relevant issues and inform relevant parties, and actively contribute to setting the direction and strategy for GS-GSC
Develop and maintain a network of contacts within NN Denmark, GS GSC and affiliates as well as external collaborators
Active member of the GS-GSC Management (GS-GSCMAN) team
Provide input to organisational review
Drive continuous improvement activities, including efficiency and customer satisfaction improvements
Promote job satisfaction and team spirit within the department
Prepare course, conference and travel budget for the group
Prepare for and/or participate in audits
Follow industry trends in order to stay competitive
Ensure that direct reports work in compliance with Novo Nordisk SOP’s
Resource planning and prioritisation. Performance monitoring
Monitor performance including regulatory compliance by applying relevant metrics and inform VP of GS-GSC/QPPV/deputy QPPV on a monthly basis
Monitor KPIs by applying relevant metrics and ensure that department KPIs are met
Ensure coordination of activities and perform resource planning
Ensure optimal and flexible use of resources in the group, including timely identification and resolution of resource gaps
Secure cross-organisational collaboration with all relevant stakeholders on a daily basis and ensure adoption of global mindset
Ensure department’s time and quality compliance concerning case handling on NN products and devices
Ensure development and maintenance of departmental and functional procedures and processes related to the collection and reporting of safety data to ensure regulatory compliance
Ensure that if a safety signal or alert is identified during daily case handling, the relevant Manager of Safety Surveillance, the VP of GS-GSC, CVP of GS/QPPV and deputy QPPV is promptly informed
Candidate Profile
Bachelor/Master in life science
≥ 3 years of management experience with good people skills, ≥6 years of experience from the pharmaceutical industry Knowledge of international pharmacovigilance legislation and guidelines. Good knowledge of businesses processes including IT systems (incl. databases and web solutions) required for the establishment of efficient handling of safety information
Knowledge of GMP and GCP requirements including GXP documentation and Good communication skills, Knowledge of budgeting and forecasting, Good interpersonal skills
Ability to plan time and approaches to problems and to exercise creativity. Strong ability to coordinate and prioritise resources for ensuring department’s time.
Additional Information:
Experience: 3-6 years
Location: Bangalore
Education: Bachelor/Master in life science
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Pharmacovigilance
End Date: 31st October, 2014
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