Senior Programmer Analyst – Pharmacovigilance (PV Systems)
Location: Mumbai, Maharashtra, India
Job ID: R-01336353
Job Type: Full-Time
Category: Clinical Research / Pharmacovigilance
Work Mode: Fully Remote
About the Role
Thermo Fisher Scientific is seeking a Senior Programmer Analyst with expertise in Pharmacovigilance (PV) systems to join our global clinical research team. This role is critical in supporting the operation, maintenance, and continuous improvement of our global drug safety systems, ensuring compliance with regional and international regulatory requirements.
As part of our world-class Clinical Research and PV team, you will work closely with cross-functional teams, external vendors, and global stakeholders to optimize safety database operations and support regulatory reporting and patient safety initiatives.
Key Responsibilities
Ensure compliance with global pharmacovigilance regulations and guidance across the US, Europe, Japan, and other regions.
Maintain, troubleshoot, and optimize Argus Safety Database and other PV systems, including E2B gateways, safety signal detection tools, and workflow management platforms.
Support daily PV operations, including case processing, system maintenance, and issue resolution.
Participate in system validation, testing, and deployment of updates, business rules, and workflows within PV applications.
Develop, manage, and execute SQL queries and reports to support system setup, troubleshooting, and operational enhancements.
Contribute to the preparation and submission of aggregate safety reports, including DSURs, PSURs, and other regulatory safety deliverables.
Ensure adherence to Change Control and Computer System Validation (CSV) processes.
Collaborate effectively with global PV, IT, and regulatory teams to maintain operational efficiency and compliance.
Communicate clearly and professionally in both written and verbal English across global teams.
Work independently, managing priorities, deadlines, and complex projects with minimal supervision.
Education & Experience Requirements
Bachelor’s or Master’s degree in Computer Science, Information Technology, or a related field.
Minimum 5 years of experience in Pharmacovigilance IT systems, PV operations, or clinical IT support.
Strong practical experience with Argus Safety Database and related pharmacovigilance technologies.
Hands-on experience with SQL for querying, reporting, and data validation.
Familiarity with global PV regulatory requirements and drug safety workflows.
Skills & Competencies
Advanced problem-solving and analytical skills.
Strong organizational skills with the ability to manage multiple projects simultaneously.
Excellent verbal and written communication skills in English.
Attention to detail and strong commitment to compliance and quality.
Ability to work independently and as part of a global team.
Why Join Thermo Fisher Scientific
Global Impact: Work with international pharmacovigilance teams supporting life-changing therapies across multiple regions.
Professional Growth: Gain hands-on experience with advanced PV systems, regulatory reporting, and clinical safety workflows.
Innovation & Collaboration: Collaborate with a world-class team in a flexible, remote work environment that values your expertise.
Recognition & Development: Thermo Fisher Scientific invests in learning pathways, mentorship, and career progression opportunities.
Thermo Fisher Scientific is a world leader in serving science, enabling our clients to make the world healthier, cleaner, and safer. We are an Equal Employment Opportunity Employer committed to diversity, equity, and inclusion.
Gujarat :
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Siliguri |Illinois :
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