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Sr Programmer Analyst (Pv Systems)

Thermo Fisher Scientific
Thermo Fisher Scientific
5+ years
Not Disclosed
10 Dec. 22, 2025
Job Description
Job Type: Remote Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Title: Senior Programmer Analyst – Pharmacovigilance Systems
Location: Mumbai, Maharashtra, India
Job Type: Full-Time
Category: Pharmacovigilance / Clinical Research

Company Overview:
Thermo Fisher Scientific’s Clinical Research Services team is a global leader in advancing drug development and safety. Our clinical research portfolio, powered by PPD®, enables innovative therapies to reach patients worldwide. We combine scientific expertise, cutting-edge technology, and operational excellence to deliver quality-driven clinical and pharmacovigilance solutions.

Role Overview:
We are seeking a Senior Programmer Analyst – PV Systems to manage, maintain, and optimize global pharmacovigilance systems. The role involves supporting drug safety operations, system validation, regulatory compliance, and reporting. The ideal candidate will have strong technical expertise in PV systems, SQL proficiency, and in-depth understanding of global regulatory requirements.

Key Responsibilities:

  • Ensure compliance with global pharmacovigilance regulations (US, EU, Japan) and guidance documents.

  • Maintain and optimize Argus Safety Database and related PV systems, including E2B gateways and safety signal detection tools.

  • Support daily operations, troubleshooting, and maintenance of safety applications to ensure reliable case processing.

  • Participate in system validation, testing, and deployment of Argus Safety updates, workflows, and business rules.

  • Develop and manage SQL queries and reports for system setup, troubleshooting, and issue resolution.

  • Contribute to the preparation and submission of aggregate safety reports, such as DSURs and PSURs.

  • Ensure adherence to change control and computer system validation (CSV) processes.

  • Collaborate with cross-functional teams and external vendors to ensure smooth operations and compliance.

  • Communicate clearly in written and spoken English with internal and external stakeholders.

  • Work independently, managing priorities and deadlines effectively.

Qualifications:

  • Bachelor’s or Master’s degree in Computer Science, IT, or a related field.

  • Minimum of 5 years of experience in Pharmacovigilance or Clinical IT Operations.

  • Practical experience with Argus Safety and associated PV technologies.

  • Hands-on experience with SQL for data management and reporting.

  • Excellent problem-solving, analytical, and communication skills.

  • Proficiency in written and spoken English.

Why Join Thermo Fisher Scientific:

  • Contribute to global drug safety and pharmacovigilance operations.

  • Work with cutting-edge PV technologies in a world-class clinical research environment.

  • Collaborate with cross-functional and global teams to advance patient safety and regulatory compliance.

Apply Now: Be part of Thermo Fisher Scientific as a Senior Programmer Analyst (PV Systems) and play a pivotal role in supporting global drug safety operations.