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ASSOCIATE DIRECTOR, DRUG SAFETY SYSTEMS AND 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>Associate Director, Drug Safety Systems and Information ManagementDrug Safety | South San Francisco, CA, United StatesSummary:The Associate Director, 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 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.* 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.* Support the safety database functionalities to ensure compliant submission of safety reports to regulatory authorities and partner companies* Other duties as assigned.-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 drug safety skills are in line with the business need, and that staff have a strong awareness and understanding of the appropriate worldwide safety regulations.* Assist in development and maintenance of the Safety Systems division budget items.* Train appropriate Drug Safety personnel in the use of Onyx safety systems and related SOPs and policies.-Management of Direct Reports* Mentor, train and supervise staff at a functional level.* Ensure each new direct report is on-boarded and trained per Onyx and departmental guidelines, work instructions, and SOPs.* Review and authori
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<tr><td valign="top" width="450"><b>Associate Director, Drug Safety Systems and Information ManagementDrug Safety | South San Francisco, CA, United StatesSummary:The Associate Director, 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 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.* 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.* Support the safety database functionalities to ensure compliant submission of safety reports to regulatory authorities and partner companies* Other duties as assigned.-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 drug safety skills are in line with the business need, and that staff have a strong awareness and understanding of the appropriate worldwide safety regulations.* Assist in development and maintenance of the Safety Systems division budget items.* Train appropriate Drug Safety personnel in the use of Onyx safety systems and related SOPs and policies.-Management of Direct Reports* Mentor, train and supervise staff at a functional level.* Ensure each new direct report is on-boarded and trained per Onyx and departmental guidelines, work instructions, and SOPs.* Review and authori
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