Associate Manager – Safety Data & Pharmacovigilance Systems (Remote, India)
Category: Clinical Research / Pharmacovigilance
Job Type: Full-Time
Work Mode: Fully Remote
Location: India (Remote)
Job ID: R-01333530
Job Overview
Thermo Fisher Scientific is seeking an experienced Associate Manager – Safety Data & Pharmacovigilance (PV) Systems to support global drug safety operations within its PPD® Clinical Research Services portfolio. This senior technical role is responsible for leading safety data management deliverables, maintaining pharmacovigilance systems, and ensuring high-quality, compliant safety data outputs across global clinical development and post-marketing programs.
The role offers the opportunity to work remotely while collaborating with global pharmacovigilance, clinical, regulatory, and IT teams to support patient safety and regulatory compliance worldwide.
Role Summary
As an Associate Manager – Safety Data & PV Systems, you will lead Global Patient Safety (GPS) safety data management and system maintenance activities. You will serve as a subject matter expert for safety databases, support signal detection and risk management activities, and ensure seamless operation of safety systems in alignment with global regulatory requirements.
Key Responsibilities
Lead and oversee GPS Safety Data Management and Safety System Maintenance deliverables
Manage and monitor safety-related mailboxes, including unblinded data, in compliance with SOPs
Serve as the primary technical expert for configuration, administration, and maintenance of Oracle Argus Safety and related PV systems
Support daily operations, troubleshooting, and issue resolution for safety databases
Assist with system validation, testing, upgrades, and deployment of Argus workflows and business rules
Generate, validate, and customize safety reports, line listings, and analytics using Argus and associated BI tools
Collaborate with Pharmacovigilance, Clinical, Regulatory, and IT teams to ensure compliance with FDA, EMA, PMDA, ICH, and other global regulations
Participate in change management, system enhancements, and integration initiatives
Support audit and inspection readiness activities, including validation documentation and system inspections
Perform quality control of aggregate safety reports such as DSURs and PSURs
Contribute to the development and maintenance of safety SOPs, work instructions, templates, and Safety Management Plans
Partner with internal teams and external vendors to resolve safety system configuration issues
Stay current with evolving PV regulations and technology trends and share insights with stakeholders
Identify process improvement opportunities to enhance efficiency and data quality
Required Education & Experience
Bachelor’s degree in Life Sciences, Information Technology, or a related discipline
Minimum 7+ years of overall experience in Pharmacovigilance, Safety Data Management, Clinical Research, or Safety IT
At least 3+ years of hands-on experience with safety database systems such as Oracle Argus Safety or ArisG, including workflow management
Strong knowledge of global pharmacovigilance regulations across US, EU, and Asia-Pacific regions
Equivalent combination of education, training, and practical experience will be considered
Key Skills & Competencies
In-depth understanding of pharmacovigilance regulatory requirements and guidance (FDA, EMA, PMDA, ICH)
Proficiency in safety database systems, E2B gateways, signal detection tools, and PV analytics platforms
Strong knowledge of MedDRA coding and end-to-end safety case processing workflows
Solid experience with aggregate safety reporting (DSUR, PSUR)
Advanced Excel skills; SQL knowledge is an advantage
Familiarity with electronic PV systems, dashboards, and data visualization tools
Strong quality mindset with experience in metrics, KPIs, and quality management processes
Excellent written and verbal communication skills in English
Ability to work independently in a remote environment and manage multiple complex deliverables
Strong collaboration, stakeholder management, and vendor coordination skills
Why Join Thermo Fisher Scientific
Thermo Fisher Scientific is a global leader in serving science, enabling customers to make the world healthier, cleaner, and safer. Through its PPD® clinical research business, the organization supports innovative clinical trials across more than 100 countries, offering employees meaningful work, global exposure, and long-term career growth opportunities.
Equal Opportunity Statement
Thermo Fisher Scientific is an equal opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, religion, gender identity, sexual orientation, disability, veteran status, or any other legally protected characteristic.
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