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MANAGER, DRUG SAFETY SYSTEMS & INFORMATION MANAGEMENT
Job Field: Security
Location: South San Francisco, CA
Salary: $Not stated
Location: South San Francisco, CA
Salary: $Not stated
JOB SUMMARY:
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<tr><td valign="top" width="450"><b>Manager, Drug Safety Systems & Information ManagementDrug Safety | South San Francisco, CA, United StatesSummary / Overall Purpose:The Manager, Drug Safety Systems and Information Management, position encompasses a key role in managing Onyx’s safety systems (including ARISg and associated tools) and other related systems and technologies of the Drug Safety department associated with both investigational and marketed products. This role provides an outstanding opportunity to work in a matrix environment and collaborate with colleagues from IT, Biometrics, Regulatory, QA, and Medical Information.Essential/Primary Duties, Functions and Responsibilities:Safety Systems and Information Management Responsibilities:* Manage the lifecycle of ARISg and other safety systems (e.g., signal detection and evaluation tools) in accordance with our project management methodology which includes development of scope, gathering business requirements and functional specifications, implementation, testing, deployment and ongoing maintenance.* Support the Drug Safety team in all ARISg safety database related functions including troubleshooting issues and liaising with IT and Aris Global representatives to facilitate issue tracking and resolution.* Perform ARISg database administrator activities by maintaining codelist, database libraries and user roles and responsibilities.* Ensure timely updates of MedDRA and WHO-DD coding dictionaries * Participate in the development, validation and management of necessary line-listings, aggregate summaries, data exports or customized reports of safety data* Conduct routine and ad hoc data extractions for regulatory purposes (e.g., PSURs, DSURs, quarterly safety reports) to assist in responding to regulatory authority queries, and for other internal team uses* Facilitate the reconciliation of ARISg safety data with groups external to Onyx Drug Safety (e.g., Data Management staff for clinical studies, Drug Safety personnel from partner companies) by ensuring appropriate line listings and reports are available for manual review or through development of electronic reconciliation programs.* Manage the registration, testing and maintenance of all electronic submissions processes with external parties (e.g., E2B reporting with Eudravigilance) in both pre-authorization and post-marketing environments* In collaboration with Drug Safety and IT, evaluate future software releases for existing systems to determine whether release should be implemented. * Ensures delivered solutions are compliant with all associated regulatory requirements and obligations (e.g., 21 CFR Part 11)* Interact with applicable external partners on all safety database issues and questions, including managing processes for data integration and/or migration from other external safety databases* Other duties as assignedAdverse Event Case Management Responsibilities:* Ensure that all safety reports received from any source (clinical trials and post-marketing) can be triaged, scheduled, processed, and reported utilizing ARISg according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures* Ensure safety database availability to track reports in the Workflow to manage departmental workload and to ensure adherence with processing timelines* Support the safety database functionalities to ensure compliant submission of safety reports to regulatory authorities and partner companies Departmental and Line Management Responsibilities:* Assist in monitoring industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and recommend changes and upgrades to applicable existing departmental systems, SOPs and policies* Develop and maintain departmental or cross functional SOPs, policies and working guidelines for the use and maintenance of ARISg database and other safety systems* Ensure that new hires are suitably qualified and that personnel are developed to ensure that their
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<tr><td valign="top" width="450"><b>Manager, Drug Safety Systems & Information ManagementDrug Safety | South San Francisco, CA, United StatesSummary / Overall Purpose:The Manager, Drug Safety Systems and Information Management, position encompasses a key role in managing Onyx’s safety systems (including ARISg and associated tools) and other related systems and technologies of the Drug Safety department associated with both investigational and marketed products. This role provides an outstanding opportunity to work in a matrix environment and collaborate with colleagues from IT, Biometrics, Regulatory, QA, and Medical Information.Essential/Primary Duties, Functions and Responsibilities:Safety Systems and Information Management Responsibilities:* Manage the lifecycle of ARISg and other safety systems (e.g., signal detection and evaluation tools) in accordance with our project management methodology which includes development of scope, gathering business requirements and functional specifications, implementation, testing, deployment and ongoing maintenance.* Support the Drug Safety team in all ARISg safety database related functions including troubleshooting issues and liaising with IT and Aris Global representatives to facilitate issue tracking and resolution.* Perform ARISg database administrator activities by maintaining codelist, database libraries and user roles and responsibilities.* Ensure timely updates of MedDRA and WHO-DD coding dictionaries * Participate in the development, validation and management of necessary line-listings, aggregate summaries, data exports or customized reports of safety data* Conduct routine and ad hoc data extractions for regulatory purposes (e.g., PSURs, DSURs, quarterly safety reports) to assist in responding to regulatory authority queries, and for other internal team uses* Facilitate the reconciliation of ARISg safety data with groups external to Onyx Drug Safety (e.g., Data Management staff for clinical studies, Drug Safety personnel from partner companies) by ensuring appropriate line listings and reports are available for manual review or through development of electronic reconciliation programs.* Manage the registration, testing and maintenance of all electronic submissions processes with external parties (e.g., E2B reporting with Eudravigilance) in both pre-authorization and post-marketing environments* In collaboration with Drug Safety and IT, evaluate future software releases for existing systems to determine whether release should be implemented. * Ensures delivered solutions are compliant with all associated regulatory requirements and obligations (e.g., 21 CFR Part 11)* Interact with applicable external partners on all safety database issues and questions, including managing processes for data integration and/or migration from other external safety databases* Other duties as assignedAdverse Event Case Management Responsibilities:* Ensure that all safety reports received from any source (clinical trials and post-marketing) can be triaged, scheduled, processed, and reported utilizing ARISg according to ICH-GCP guidelines, regulatory requirements and company SOPs and procedures* Ensure safety database availability to track reports in the Workflow to manage departmental workload and to ensure adherence with processing timelines* Support the safety database functionalities to ensure compliant submission of safety reports to regulatory authorities and partner companies Departmental and Line Management Responsibilities:* Assist in monitoring industry best practices, and changes in global safety regulations and guidelines for marketed and investigational products, and recommend changes and upgrades to applicable existing departmental systems, SOPs and policies* Develop and maintain departmental or cross functional SOPs, policies and working guidelines for the use and maintenance of ARISg database and other safety systems* Ensure that new hires are suitably qualified and that personnel are developed to ensure that their
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