Job Title: Associate Manager – Safety Data and PV Systems
Category: Pharmacovigilance / Clinical Research
Location: Remote, India
Employment Type: Full-Time
Job ID: R-01333530
Thermo Fisher Scientific is seeking an experienced Associate Manager in Safety Data and Pharmacovigilance (PV) Systems to join our global Clinical Research Services team. In this role, you will lead deliverables for Global Patient Safety (GPS), overseeing safety data management and PV system operations. Your work will ensure high-quality data outputs to support safety signal management, risk management, and regulatory compliance across clinical and post-marketing studies.
This fully remote position offers exposure to international pharmacovigilance operations, advanced safety database systems, and collaboration with global teams, clients, and vendors.
Serve as the technical lead for the configuration, maintenance, and administration of Oracle Argus Safety system.
Manage GPS mailboxes, including unblinded data, ensuring accurate and compliant processing.
Support day-to-day operation, troubleshooting, and system updates for Argus Safety workflows and business rules.
Generate, validate, and customize safety reports using Argus reporting tools and associated business intelligence platforms.
Collaborate with pharmacovigilance, clinical, and regulatory teams to align safety data management with FDA, EMA, PMDA, and ICH guidelines.
Participate in change management, audit readiness, system inspections, validation reports, and compliance documentation.
Create and maintain procedural documents, including Safety Management Plans, SOPs, work instructions, job aids, and templates.
Co-create and collaborate with client functions such as Medical Information, Data Management, BIS, and Quantitative Science regarding PV technical aspects.
Continuously review processes and tools to suggest improvements and efficiencies.
Provide training on safety data management systems and workflows to team members.
Complete additional projects and tasks assigned by the Head of GPS Operations or line manager.
Education: Bachelor’s degree in Life Sciences, Information Technology, or a related field.
Experience:
Minimum 7 years in IT, Safety, Clinical Research, or Pharmacovigilance.
At least 3 years of hands-on experience with safety database systems (e.g., Argus or ArisG), including workflow management.
Strong knowledge of global pharmacovigilance regulatory requirements (EU, US, Japan) and PV best practices.
Proficiency in electronic PV systems, including Argus Safety, E2B gateways, signal detection tools, dashboards, and safety reporting systems.
Solid understanding of clinical and post-marketing safety event collection, workflow-based case processing, MedDRA coding, and aggregate safety reports (DSUR, PSUR).
Advanced Excel skills, SQL knowledge is a plus.
Excellent written and verbal communication in English.
Strong analytical, organizational, and problem-solving skills.
Ability to work independently, manage multiple deliverables, and prioritize effectively.
Collaborative mindset with the ability to work across global teams and vendors.
High attention to detail and commitment to quality and compliance standards.
Global Exposure: Work with international teams and contribute to PV operations across multiple regions and therapeutic areas.
End-to-End Impact: Influence the collection, analysis, and reporting of safety data that directly affects patient safety and regulatory compliance.
Professional Growth: Gain expertise in advanced PV systems, safety analytics, regulatory guidelines, and clinical trial operations.
Mission-Driven Work: Contribute to Thermo Fisher Scientific’s mission to make the world healthier, cleaner, and safer while supporting life-changing therapies worldwide.
Thermo Fisher Scientific is a global leader in serving science, with over $44 billion in annual revenue. With a workforce of 90,000+ colleagues, we provide innovative technologies, laboratory solutions, and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, and Patheon.
Equal Opportunity Employer: Thermo Fisher Scientific is committed to diversity, equity, and inclusion and provides equal employment opportunities to all employees and applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other legally protected status.
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