FSP Associate Manager, Safety Data & Systems

This is a fully remote position, open to applicants in North Carolina.

📋 Description

• Oversee deliverables for Global Patient Safety regarding safety data management and the maintenance of safety systems.

• Ensure high-quality data outputs for safety signal management, risk management, and generation of safety evidence.

• Manage and supervise relevant GPS mailboxes, including unblinded data.

• Act as the primary technical resource for the configuration, maintenance, and administration of the Oracle Argus Safety system.

• Provide daily support for Argus Safety operations and troubleshooting to ensure reliable and compliant processing of drug safety cases.

• Assist with the validation, testing, and deployment of Argus updates, workflows, and business rules.

• Create, validate, and tailor safety reports and analytics utilizing Argus reporting tools and business intelligence platforms.

• Work in collaboration with pharmacovigilance, clinical, and regulatory teams to ensure alignment of safety data management with FDA, EMA, PMDA, and ICH standards.

• Engage in change management initiatives to enhance Argus workflows and system integrations.

• Contribute to audit readiness, system inspections, validation reports, and compliance documentation.

• Collaborate with internal systems teams, BIS, and safety vendors on issues related to safety database configuration.

• Generate and conduct quality control on aggregate reports and line listings.

• Develop procedural documents, which include Safety Management Plans, SOPs, work instructions, job aids, forms, and templates.

• Partner with client functions on the technical setup and operations of pharmacovigilance.

• Stay updated on regulatory and pharmacovigilance technology guidelines and communicate updates with GPS and clients.

• Participate in training sessions related to safety data management.

• Proactively review processes and tools, suggesting improvements for efficiency.

• Complete additional tasks and projects as assigned by the line manager or Head of GPS Operations.

⛳️ Requirements

• A Bachelor's degree (or equivalent) in life sciences, Information Technology, or a related field is required.

• A minimum of 7 years of pertinent experience in IT, Safety, Clinical Research, or Pharmacovigilance is necessary.

• At least 3 years of demonstrable experience with safety database systems such as Argus or ArisG, including management of workflows.

• Strong understanding of global pharmacovigilance requirements and practices in the EU, US, and Asia-Pacific regions.

• Good knowledge of applicable pharmacovigilance regulatory requirements and guidance documents for Europe, the US, and Japan.

• Proficient computer skills in current office applications are essential.

• Expertise in Excel is required; experience with SQL is an advantage.

• Proficient in safety database systems like Argus, with knowledge of E2B gateways and safety signal detection tools.

• Skilled in electronic Safety/PV systems for data visualization, analysis, and dashboards.

• A comprehensive understanding of the end-to-end collection and reporting of clinical and post-marketing safety events, as well as workflow-based case processing and the MedDRA dictionary.

• Solid grasp of the development and submission processes for aggregate safety reports, such as DSUR and PSUR.

• A thorough understanding of quality management processes, metrics, and KPIs.

• Fluent in written and spoken English is required.

• Ability to work independently with minimal supervision while prioritizing tasks effectively.

• Capable of completing multiple complex deliverables within strict deadlines.

• Ability to work efficiently within a team environment.

• An equivalent and sufficient combination of education and experience or proven practical expertise in all necessary skills.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.