Summary of Duties and Responsibilities
The Safety Systems Analyst III will be part of the Corporate Drug Safety team and will assist with safety systems-related activities for Corporate Drug Safety Operations including aggregate reports, signal detection, and database systems support. The Systems Safety Analyst will be responsible for providing technical expertise on safety systems, specifically the Argus Safety database. The role is critical to pharmacovigilance to support and maintain the overall adverse event reporting system, electronic reporting to health authorities and ensuring compliance to the relevant regulatory requirements, policies and standards.
Collaborate with the database hosting vendor to manage change control as needed to support Corporate Drug Safety business needs reflected in system configuration.
Organize, track, and implement database change control requests including, but not limited to, product configuration, protocol configuration, user access changes, etc. as per procedures.
Provide solutions for database requests received from system users (e.g., enhancement, new functionality requests, and troubleshooting).
Create and deliver standardized/validated/accurate data retrievals from the safety database for signal detection activities, both routine and/or ad hoc queries.
Support generation of aggregate data for management committee reviews, inspections/audits, and ad-hoc reports.
Setup and troubleshoot E2B reporting. Review and resolve acknowledgement failures.
Author, review and/or execute Validation test scripts in the implementation and testing of change controls or database upgrades.
Manage MedDRA and WHO Drug dictionaries including upgrades and recoding processes.
Manage adjunct software systems in support of compliance related activities.
Ensure quality and timely end user support through change control management with the hosting vendor.
Ensure compliance with relevant Impax policies and procedures.
Bachelor's degree in MIS or information technology related field required.
6 years of experience supporting a drug safety database (Argus Safety preferred) in a pharmaceutical company required.
Experience in developing custom reports using PL/ SQL is preferred.
Experience in working with standard reporting tools like Cognos/Business Objects required.
Experience in conducting E2B pilots with Regulatory Agencies and partners required.
Experience in MS Office tools required.
5-8 years of experience and detailed knowledge of Argus Safety configuration required.
Excellent people and project management skills preferred.
Knowledge of Signal Detection systems (e.g. Empirica), E2B R3, and IDMP preferred.
Excellent prioritization skills and strong analytical/problem solving skills preferred.
Excellent oral and written communication skills and commitment preferred.
Licenses and Certifications