Senior Programmer Analyst – Pharmacovigilance (Oracle Argus)
Location: Remote, India
Job Type: Full-Time
Category: Clinical Research / Pharmacovigilance
Job ID: R-01332387
Work Model: Fully Remote
About the Role
Thermo Fisher Scientific is seeking a Senior Programmer Analyst to serve as a subject matter expert for Pharmacovigilance (PV) Safety database operations. The role focuses on Oracle Argus configuration, maintenance, and reporting, ensuring compliance with SOPs, policies, industry standards, and global regulatory requirements. You will collaborate with cross-functional teams and clients to deliver high-quality technical solutions, support system implementation, and enhance PV safety database operations.
Key Responsibilities
Serve as a technical expert for day-to-day Oracle Argus application configuration, system administration, and maintenance.
Collaborate with PV business users to understand requirements and recommend efficient, compliant solutions.
Create custom and ad-hoc safety reports using built-in tools, OBIEE, or SQL, ensuring industry-standard best practices.
Develop, validate, and deliver aggregate safety reports in compliance with regulatory and internal requirements.
Assist with internal and external audits of the PV Safety database.
Provide programming support for safety data review, ad-hoc reporting, and other project-specific activities.
Lead project initiatives, ensuring deliverables are achieved on time, within scope, and to high-quality standards.
Review processes and provide recommendations for process improvement and operational efficiency.
Support project teams and clients, seeking feedback to optimize deliverables and ensure client satisfaction.
Estimate effort for bidding activities or cost construction as required.
Required Qualifications & Experience
Education: Bachelor’s degree in Computer Science, Life Sciences, or related field.
Experience: Minimum 5+ years of experience in PV database programming, configuration, and reporting, preferably with Oracle Argus.
Proven ability to manage complex PV safety database systems in compliance with SOPs, GxP, and regulatory standards.
Skills & Competencies
Strong expertise in Oracle Argus safety database administration, configuration, and workflow management.
Proficiency in SQL, OBIEE, and report development.
Experience in aggregate safety reporting, data validation, and compliance audits.
Solid understanding of Pharmacovigilance processes, safety data trends, and regulatory guidelines (ICH, FDA, EMA).
Strong problem-solving, analytical, and critical-thinking skills.
Excellent oral and written communication skills with attention to detail.
Ability to manage multiple complex assignments in a fast-paced, collaborative environment.
Demonstrated ability to mentor junior staff and support cross-functional teams.
Why Join Thermo Fisher Scientific
As a Senior Programmer Analyst, you will play a pivotal role in supporting global PV safety operations, ensuring accurate and compliant reporting for life-saving therapies. Join a leading global CRO and contribute to advancing healthcare worldwide.
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