Senior Programmer Analyst – Pharmacovigilance Systems
Company: Thermo Fisher Scientific / PPD Clinical Research
Location: Mumbai, Maharashtra, India (Remote / Fully Remote)
Job Type: Full-Time
Category: Pharmacovigilance / Clinical IT / Drug Safety
Experience Required: 5+ years
Job Overview
Thermo Fisher Scientific is seeking a Senior Programmer Analyst – PV Systems to manage, maintain, and optimize global pharmacovigilance systems. This role focuses on ensuring regulatory compliance, system reliability, and data integrity in drug safety operations across multiple regions including the US, EU, and Japan.
The ideal candidate will combine technical expertise in PV systems, regulatory knowledge, and proficiency in SQL and data management tools to support day-to-day operations, system validation, and reporting. This is a remote-friendly position offering a unique opportunity to contribute to life-saving pharmacovigilance initiatives on a global scale.
Key Responsibilities
Pharmacovigilance Systems Management
Ensure compliance with global PV regulations and guidance documents (FDA, EMA, PMDA, and other international bodies)
Maintain and troubleshoot Argus Safety Database and associated PV systems, including E2B gateways and safety signal detection tools
Support system updates, workflow configuration, and business rule deployment in PV applications
Develop, manage, and execute SQL queries and reports to support system setup, troubleshooting, and data analysis
Operational Support & Compliance
Participate in system validation (CSV), testing, and deployment of PV system updates
Support aggregate safety reporting (DSURs, PSURs) by ensuring accurate data extraction and system readiness
Collaborate with internal teams and external vendors to maintain regulatory compliance and operational efficiency
Implement change control and ensure proper documentation of all system modifications
Communication & Collaboration
Produce clear technical documentation and status updates for management and stakeholders
Communicate complex technical and regulatory issues effectively in written and oral English
Work independently, prioritize tasks, and meet project deadlines with minimal supervision
Education & Experience
Education:
Bachelor’s or Master’s degree in Computer Science, Information Technology, or a related field
Experience:
Minimum 5 years in Pharmacovigilance systems, Clinical IT operations, or PV database management
Hands-on experience with Argus Safety, E2B standards, and other PV technologies
Proficiency in SQL and database management
Skills & Competencies
Strong understanding of global pharmacovigilance regulatory requirements
Ability to manage complex PV systems, troubleshoot issues, and implement solutions
Excellent analytical, problem-solving, and technical skills
Strong communication skills and ability to interact with global teams and vendors
Detail-oriented, proactive, and able to manage multiple priorities efficiently
Knowledge of computer system validation (CSV), change control, and audit readiness
Why Join
Contribute to global drug safety initiatives supporting patients worldwide
Gain exposure to international PV operations across multiple therapeutic areas
Advance your career in pharmacovigilance IT and drug safety systems
Work remotely while collaborating with cross-functional global teams
Join a leading CRO with a reputation for scientific excellence and operational quality
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Siliguri |Illinois :
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