||: June 15, 2020
||: Product Development/Product Consulting
This role is responsible for overall development, configuration and maintenance of Argus Safety.
- 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.
- 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 firstname.lastname@example.org by specifying the Job Code.