Associate Manager, Safety Data and Systems

This is a fully remote position, open to applicants in United States.

📋 Description

• Oversee deliverables for GPS Safety Data Management as well as Safety System Maintenance tasks.

• Ensure high-quality data outputs for Safety Signal Management, Risk Management, and the generation of Safety Evidence.

• Manage and monitor relevant GPS mailboxes, which include unblinded data.

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

• Support daily operations and troubleshooting of the Argus Safety application.

• Assist in system validation, testing, and the deployment of Argus Safety updates, workflows, and business rules.

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

• Collaborate with pharmacovigilance, clinical, and regulatory teams to ensure safety data management aligns with global regulatory standards.

• Engage in change management processes to improve system workflows and integrations.

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

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

• Produce and conduct quality checks on aggregate reports and line listings.

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

• Collaborate with argenx functions regarding the technical aspects, setup, and operation of pharmacovigilance.

• Stay updated on regulatory and pharmacovigilance technology guidelines and disseminate this information.

• Participate in training related to safety data management.

• Review processes and tools, proposing enhancements and efficiencies.

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

⛳️ Requirements

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

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

• At least 7 years of relevant experience in IT, Safety, Clinical Research, or Pharmacovigilance is required.

• A minimum of 3 years of demonstrated experience with safety database systems such as ARGUS or ArisG, including workflow management.

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

• Adequate computer skills in current office applications are essential.

• Proficiency in Excel is mandatory.

• Experience with SQL is an advantage.

• Expertise in safety database systems like Argus is required.

• Knowledge of technical systems relevant to safety/pharmacovigilance, including E2B gateways and safety signal detection tools.

• Proficient in electronic systems used for safety/pharmacovigilance data visualization, analysis, and dashboards.

• Understanding of the complete process for clinical and post-marketing safety event collection and reporting, including workflow-based case processing and the MedDRA dictionary.

• Familiarity with the development and submission of aggregate safety reports such as DSUR and PSUR.

• Knowledge of quality management processes, metrics, and KPIs.

• Fluent in written and spoken English is required.

• Capable of working independently with minimal oversight and effectively prioritizing tasks.

• Ability to manage multiple complex deliverables within tight deadlines.

• Effectively function in a team environment.

• An equivalent and suitable combination of education and experience, or proven practical expertise in all required skills is acceptable.

🏝️ Benefits

• Annual base salary ranging from $88,000.00 to $121,000.00 USD.

• Eligibility to participate in short-term incentive programs.

• Eligibility for long-term incentive programs.

• Comprehensive benefits package.

• Retirement savings plans.

• Health benefits.

• Inclusive work environment.

• Equal consideration for employment without discrimination.