This role is responsible for overall development, configuration and maintenance of Argus Safety.
Detailed Description:
Recommend course of action regarding project/program issues and concerns, implement mitigation plans, then escalate risks and issues as necessary
Responsible for following client’s System Life-Cycle (SLC) and Computer System Validation (CSV) procedures.
Responsible for the overall development, configuration and maintenance of Argus Safety making use of state of the art, modern technologies
Advanced level configuration and maintenance of product and licence information, reporting rules, clinical studies and user information within Argus Safety
Investigate, configure and implement Argus Safety functionality to support efficient case processing such as use of Work Lists, Prioritisation, Field Validations and Automation functionalities
Implement and manage the connections to Argus Safety from external systems, such as E2B import and export of electronic files from Regulatory Agencies, licence partners and Clinical Study databases via a Gateway
Responsible for investigating and resolving issues relating to Argus Safety escalating to the IT Service teams or the database vendor as required.
Ensuring Argus Safety validation status is maintained and that all processes relating to the database are documented and robust.
Responsible for maintaining knowledge of Pharmacovigilance Regulatory Requirements, assessing the impact of any changes on Argus Safety and our processes and the planning of any necessary updates.
Collaborate externally and attend relevant industry conferences and information days to maintain knowledge and understanding of best industry practices for managing safety systems.
To collaborate internationally with the vendor team with regards to Argus Safety up-grades, validation and configuration.
Participation with IT in IQ, OQ, and PQ testing and validation during system upgrades and migrations.
Job Requirements:
He/she should possess minimum of a Bachelor’s Degree in Engineering or Computer Science or a directly related field.
He/she should have Atleast 2 – 7 years of relevant experience.
To apply for the above position, please send your word resumes to careers@vitrana.com by specifying the Job Code.
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