Safety Systems Business Lead (Senior Manager)

Job Location(s) IN-Bangalore
Job Number
Job Category
Drug Safety/Pharmacovigilance
Position Type

Job Overview

- This role would be equivalent to a Senior Manager primarily managing Argus safety system including set up and ongoing maintenance, and other new safety systems as needed
- Contribute to the development and execution of required technology and processes in support of high profile projects in order to effectively prepare DSS for evolving business needs
- Own the design and development of process design, technical systems, and performance, measure, metrics, and reporting
- Work with DSS internal and external cross-functional team members to identify and develop solutions for complex business issues, partnering closely with key internal and external stakeholders to ensure active exchange of information and communication among team
- Provide analysis and guidance to the design, development, and delivery of training programs and support materials in the areas of process, technical solutions, and business metrics reporting
- Oversee and coordinate updates and integration of content and materials for various DSS internal systems and tools, including, but not limited to, global tracking tools, global document repositories and work spaces, and workflow management systems
- Identify methods and measure the effectiveness of processes, set targets, track results, and continuously improve
- Perform other duties as appropriate


- Bachelor degree or above in health-care or IT/ Computer systems related field.
- Expert knowledge of drug safety databases and related systems and processes
- Working knowledge of global regulatory requirements and guidelines for drug safety reporting
- Understanding of Pharmacovigilance internal and external environment including methodological and technical aspects
- Ability to analyze and communicate complex issues and their strategic implications for systems and processes
- Demonstrated ability to work effectively with a sense of urgency in a dynamic, cross-functional matrix environment


- 10+ years of working in clinical trial management, clinical operations, and/or project management experience including a minimum of 5 years of experience in a leadership capacity; or equivalent combination of education, training, and experience
- 5+ years of intensive experience working in drug safety/pharmacovigilance in the pharmaceutical or biotech industry or similar setting
- 3+ years of Argus systems and/or business analysis experience


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