Argus Safety & PV Applications Support & Upgrade

Talent Groups partners with many different types of life sciences companies, including Pharmaceutical, Medical Device, and Biotech companies to recruit the top talent available in the market, with the niche skills you need for your projects.

Our client is a global biopharmaceutical company focused on developing innovative medicines to address unmet needs of people living with mental illness, addiction, and cancer.

CHALLENGE

Our client was looking for support in their Drug Safety Pharmacovigilance Systems & Analytics team. They needed a consultant to help them in database validation and configuration activities, in the fulfillment of data requests and process improvements and resolution of technical issues.

They had several projects to complete, one of which was to enhance their Oracle Argus system, to include the upcoming regulatory requirements for combination (drug & device) reporting. They needed to extend the system to automate the submissions to the regulatory agencies worldwide.

APPROACH

Talent Groups provided a consultant that had experience with the safety system (Argus Safety) including PV operations, technical, and analytical skills as well as strong knowledge of relevant FDA/GCP/ICH guidelines and AE reporting requirements.

Our consultant collaborated cross-functionally with teams such as PV Operations, Aggregate Reporting & Signaling, Quality & Compliance, Clinical, Regulatory, Computer Systems Validation, Clinical Quality Assurance, Epidemiology, and R&D, to understand and analyze the impact and scope of the projects.

They developed and implemented system changes including product configuration, study/protocol configuration, workflow and process changes, user access changes, etc. They also organized data to facilitate analysis for aggregate data review as well as for signaling activities.

IMPACT

Our consultant integrated into the team at our client site and provided his expertise on several projects. They were able to successfully support this team for over 2 ½ years. After the successful completion of the projects, the client was able to manage/govern all the local/global submissions in the Safety System. They also harmonized all their processes around the reporting and signaling activities.