FSP Associate Manager, Safety Data & Systems

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

* 1 GENERAL INFORMATIONName of Role: Associate Manager, Safety Data & Systems, GPS OperationsFunction: 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

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