Associate Manager, Safety Data and PV Systems

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October 31

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Thermo Fisher Scientific

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Biotechnology • Pharmaceuticals • Science

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

10,000+ employees

Founded 1956

🧬 Biotechnology

💊 Pharmaceuticals

🔬 Science

📋 Description

• 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.

🎯 Requirements

• 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) • 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 • Fluent communication in written and spoken English required • Ability to communicate effectively and collaborate successfully across functions and with vendors.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off • Specialized training and development programs