What are the responsibilities and job description for the Safety system manager position at Unicon Pharma Inc?
Responsibilities:
- Please note any travel-related expenses would have to be absorbed by the candidate.
- Assists in the implementation of project specific safety database configurations to meet the regulatory and business needs of the CSPV department.
- Participates in system validation activities for the safety database and other safety-related systems. Perform quality checks on configuration changes performed by the database service provider; Identify discrepancies between the request and the implementation and resolve or initiate their resolution.
- Serve as a system administrator and perform configurations/master data updates like code lists, user access, reporting rules, product, and study, pilot tests with E2b partners in Development environment. Work with CSPV Team(s) and DBMA team to complete the configuration forms and coordinate with the Safety system service provider to complete the needed configurations.
- Maintain best practices for safety database configurations, customizations, aggregate reporting, data migration, data integration, E2B Gateway reporting set-up, interface with EDC and other new automation initiatives.
- Assists with data management of safety-related PV systems. Other duties as assigned. Must be available to work during US Business Hours
Skills:
- Experience supporting Oracle Argus Safety is required.
- Experience in safety reporting applications is required.
- Knowledge of PV reports would be helpful. Relational database (Argus Safety database) knowledge working with Oracle and SQL is required.
- General knowledge of Electronic Data Interchange (Axway B2Bi Interchange in particular a plus), Rave Safety Gateway, E2b Pilot Test with HA.
- General knowledge about the global safety reporting requirements and ICH E2B guidelines that govern the international reporting of adverse events on investigational and marketed products are preferred.
Soft Skills:
- Candidate must have a professional, respectful, proactive demeanor.
- Able to communicate effectively and collaborate with different stakeholders and functional areas.
- Willing and able to provide support to other team members on projects; tasks; etc.
Education:
BS Computer Science/equivalent qualification with at least four (4) years of experience in Pharmacovigilance
