A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post : CRO Coordinator
Job Description
• Manage daily smooth running of Pharmacovigilance Operations outsourced to con-tract organisations/vendors in compliance with Novartis processes. This includes in-teraction with external and internal stakeholders to ensure timelines for case processing and quality are met per Novartis SOPs.
• Support Project Manager in development of forecasts and general outsourcing strat-egy for DS&E.
• Contribute to documentation, processes and set-up activities to facilitate efficient working and effective partnerships with external groups and on process improve-ment initiatives and methodologies
• Communication with the vendor TLs & QC associates on regular basis
• Monitoring & tracking of case volume for assigned cases to vendor
• Communication with vendor Team Manager and Project Manager on a fortnight & monthly meetings and reviews action logs
• Facilitate interactions between vendor team and other departments of Novartis / third party vendors for software as and when required
• Provide input on agendas, provide materials, liaise with meeting planners and man-age logistics for key meetings e.g. internal CTL meetings or external investigator meetings. Attend and present at these meetings as appropriate.
• Identify areas for process or technology improvements with regard to tasks underta-ken within the role; propose and complete a project to enhance efficiencies and promote standardization across the organization based on this.
• Manage the forecasting, identification and planning for upcoming projects. Recog-nize problems or delays and take action to prevent or address issues. Inform rele-vant project members as appropriate.
• Support Project Manager by providing data needed to review progress of engage-ment against the SLA and to resolve any issues that might have a significant impact on the project scope, costs, and schedules Key Performance Indicators (Indicate how performance for this role will be measured)
• Manage delivery of high quality Individual case safety reports according to agreed timelines and budget, ensuring adherence to international and local regulations from the vendor.
• Feedback of external and internal customers.
• Delivery of work-related project/presentation
Candidate Profile
Life sciences Graduate / Postgraduate English 3 - 5 years exp in Pharma 1 -2 years of experience in Pharmacovigilance Project Management experience preferred.
Additional Information:
Experience: 3 - 5 years
Location: Hyderabad
Education: Life sciences Graduate / Postgraduate
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: CRO
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