job title: Argus/safety analyst(vitrana)

Brief Description:

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.