Work Schedule Standard (Mon-Fri)
Environmental Conditions Office
Job Description
* 1 GENERAL INFORMATION Name of Role: Associate Manager, Safety Data & Systems, GPS Operations Function: Global Patient Safety (GPS) * 2 PURPOSE OF THE FUNCTION
* Lead deliverables for GPS Safety Data Management and Safety System Maintenance activities * Provide high quality data outputs for Safety Signal Management, Risk Management and Safety Evidence generation * Collaborate and co-create with client functions and applicable vendors as required for seamless GPS Safety Data and Systems operations
* 3 REPORTING LINE
* Sr. Director Safety Data and Systems, GPS Operations or designee
* 4 ROLES AND RESPONSIBILITIES
* Manages and monitors applicable GPS mailboxes including unblinded data * Serve as the key technical resource for the configuration, maintenance, and administration of the Oracle Argus Safety system. * Support day-to-day operation and troubleshooting of Argus Safety application to ensure reliable and compliant drug safety case processing. * Assist in system validation, testing, and deployment of Argus Safety system updates, workflows, and business rules. * Generate, validate, and customize safety reports and analytics using Argus reporting tools and associated business intelligence platforms. * Collaborate closely with the pharmacovigilance, clinical, and regulatory teams to ensure safety data management aligns with global regulatory standards (FDA, EMA, PMDA, ICH). * Participate in change management processes to enhance Argus Safety system workflows and system integrations. * Contribute to audit readiness activities, including system inspections, validation reports, and compliance documentation. * Collaborates with internal systems team, BIS and Safety vendor on issues related to Safety database configurations * Performs the generation and quality control of aggregate reports and line listings * Initiates and contributes to the development of procedural documents including but not limited to Safety Management Plans, SOPs, work instructions, job aides, forms, or templates * Collaborates and co-creates with applicable client functions (e.g. Medical Information, Data Management, Business Information Systems, Quantitative Science) in regards to pharmacovigilance technical aspects, setup and operation * Keeps up-to-date on applicable regulatory and PV tech guidelines and shares within GPS and client as applicable. * Participates in training related to safety data management * Proactively reviews processes and tools and provides suggestions for improvement and better efficiencies * Complete additional task and projects as assigned by line manager or Head of GPS Operations / designee.
* 5 SKILLS AND COMPETENCIES
* Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan) * Adequate computer skills in all current office applications * Proficiency with Excel is required, experience with SQL is a plus * Proficiency in Safety Database systems (e.g. Argus) and knowledge of other technical systems applicable to Safety /Pharmacovigilance (e.g. E2B gateway, safety signal detection tools and systems). * Proficiency in electronic systems commonly used for Safety / PV, like for data visualization and analysis, dashboards * Robust understanding of the end to end process of clinical and post-marketing safety event collection and reporting including of workflow based case processing and MedDRA dictionary * Solid understanding of the development and submission of aggregate safety reports (e.g. DSUR, PSUR) * Solid understanding of the quality management processes, metrics and KPIs * Ability to communicate effectively and collaborate successfully across functions and with vendors * Fluent communication in written and spoken English required * Ability to work independently with minimal oversight and prioritize effectively * Ability to complete multiple complex deliverables within tight timelines * Ability to function effectively in a team environment
* 6 EDUCATION, EXPERIENCE AND QUALIFICATIONS
* At least Bachelors' degree (or country equivalent) in life sciences / Information technology or other relevant field required * Solid knowledge of global (EU/US/Asia Pac) pharmacovigilance requirements and practices required * Minimum of 7 years of relevant experience in IT / Safety / Clinical Research / Pharmacovigilance overall with at least 3 years of proven experience with safety database systems (e.g. ARGUS or ArisG) including workflow management * Equivalent and adequate combination of education and experience or proven practical expertise in all of the required skills undefined
* 1 GENERAL INFORMATION Name of Role: Associate Manager, Safety Data & Systems, GPS Operations Function: Global Patient Safety (GPS) * 2 PURPOSE OF THE FUNCTION
* Lead deliverables for GPS Safety Data Management and Safety System Maintenance activities * Provide high quality data outputs for Safety Signal Management, Risk Management and Safety Evidence generation * Collaborate and co-create with client functions and applicable vendors as required for seamless GPS Safety Data and Systems operations
* 3 REPORTING LINE
* Sr. Director Safety Data and Systems, GPS Operations or designee
* 4 ROLES AND RESPONSIBILITIES
* Manages and monitors applicable GPS mailboxes including unblinded data * Serve as the key technical resource for the configuration, maintenance, and administration of the Oracle Argus Safety system. * Support day-to-day operation and troubleshooting of Argus Safety application to ensure reliable and compliant drug safety case processing. * Assist in system validation, testing, and deployment of Argus Safety system updates, workflows, and business rules. * Generate, validate, and customize safety reports and analytics using Argus reporting tools and associated business intelligence platforms. * Collaborate closely with the pharmacovigilance, clinical, and regulatory teams to ensure safety data management aligns with global regulatory standards (FDA, EMA, PMDA, ICH). * Participate in change management processes to enhance Argus Safety system workflows and system integrations. * Contribute to audit readiness activities, including system inspections, validation reports, and compliance documentation. * Collaborates with internal systems team, BIS and Safety vendor on issues related to Safety database configurations * Performs the generation and quality control of aggregate reports and line listings * Initiates and contributes to the development of procedural documents including but not limited to Safety Management Plans, SOPs, work instructions, job aides, forms, or templates * Collaborates and co-creates with applicable client functions (e.g. Medical Information, Data Management, Business Information Systems, Quantitative Science) in regards to pharmacovigilance technical aspects, setup and operation * Keeps up-to-date on applicable regulatory and PV tech guidelines and shares within GPS and client as applicable. * Participates in training related to safety data management * Proactively reviews processes and tools and provides suggestions for improvement and better efficiencies * Complete additional task and projects as assigned by line manager or Head of GPS Operations / designee.
* 5 SKILLS AND COMPETENCIES
* Good knowledge of relevant pharmacovigilance regulatory requirements and guidance documents (including Europe, US, Japan) * Adequate computer skills in all current office applications * Proficiency with Excel is required, experience with SQL is a plus * Proficiency in Safety Database systems (e.g. Argus) and knowledge of other technical systems applicable to Safety /Pharmacovigilance (e.g. E2B gateway, safety signal detection tools and systems). * Proficiency in electronic systems commonly used for Safety / PV, like for data visualization and analysis, dashboards * Robust understanding of the end to end process of clinical and post-marketing safety event collection and reporting including of workflow based case processing and MedDRA dictionary * Solid understanding of the development and submission of aggregate safety reports (e.g. DSUR, PSUR) * Solid understanding of the quality management processes, metrics and KPIs * Ability to communicate effectively and collaborate successfully across functions and with vendors * Fluent communication in written and spoken English required * Ability to work independently with minimal oversight and prioritize effectively * Ability to complete multiple complex deliverables within tight timelines * Ability to function effectively in a team environment
* 6 EDUCATION, EXPERIENCE AND QUALIFICATIONS
* At least Bachelors' degree (or country equivalent) in life sciences / Information technology or other relevant field required * Solid knowledge of global (EU/US/Asia Pac) pharmacovigilance requirements and practices required * Minimum of 7 years of relevant experience in IT / Safety / Clinical Research / Pharmacovigilance overall with at least 3 years of proven experience with safety database systems (e.g. ARGUS or ArisG) including workflow management * Equivalent and adequate combination of education and experience or proven practical expertise in all of the required skills undefined
FSP Associate Manager, Safety Data & Systems in remote at Unknown Company
This position is listed as full time and onsite.