Senior Programmer Analyst – Pharmacovigilance Systems (PV Systems)
Company: Thermo Fisher Scientific (PPD Clinical Research Services)
Job ID: R-01336353
Location: Mumbai, Maharashtra, India
Work Mode: Fully Remote
Employment Type: Full-Time
Category: Clinical Research / Pharmacovigilance Systems
Experience Level: Senior Level
Experience Required: Minimum 5 years
About the Organization
Thermo Fisher Scientific, through its PPD Clinical Research Services portfolio, is a leading global Contract Research Organization (CRO) supporting the development of innovative therapies that address some of the world’s most complex health challenges. With deep scientific, clinical, and operational expertise, the organization partners with pharmaceutical, biotech, and healthcare companies worldwide to accelerate drug development and ensure patient safety.
Role Overview
The Senior Programmer Analyst – Pharmacovigilance Systems will play a critical role in supporting, maintaining, and enhancing global drug safety systems. This position requires strong hands-on expertise in pharmacovigilance platforms, particularly Argus Safety, along with a solid understanding of global regulatory requirements and system validation processes. The role is fully remote and offers the opportunity to work within a world-class global PV and clinical IT environment.
Key Responsibilities
Ensure compliance with global pharmacovigilance regulations and guidance, including requirements from the US, Europe, and Japan.
Support the operation, configuration, troubleshooting, and maintenance of pharmacovigilance systems, including Argus Safety and E2B gateways.
Participate in system validation, testing, and deployment of Argus Safety upgrades, workflows, and business rules.
Develop, execute, and maintain SQL queries and reports to support system configuration, issue resolution, and data analysis.
Support the preparation and submission of aggregate safety reports, including DSURs and PSURs.
Ensure adherence to change control procedures and Computer System Validation (CSV) standards.
Collaborate with cross-functional teams and external vendors to ensure reliable system performance and regulatory compliance.
Communicate technical and regulatory information clearly and professionally in written and verbal English.
Work independently with minimal supervision while effectively managing priorities and deadlines.
Experience Required
Minimum 5 years of experience in pharmacovigilance systems, clinical IT operations, or drug safety technology roles.
Proven hands-on experience supporting Argus Safety and related pharmacovigilance platforms.
Demonstrated experience working in regulated environments with global safety requirements.
Educational Qualifications
Bachelor’s or Master’s degree in Computer Science, Information Technology, or a related discipline.
Required Skills & Competencies
Strong practical expertise in Argus Safety and associated PV technologies.
Hands-on experience with SQL for reporting, data analysis, and system troubleshooting.
Solid understanding of global pharmacovigilance regulations and reporting standards.
Excellent analytical, problem-solving, and documentation skills.
Strong written and verbal communication skills in English.
Why Join Thermo Fisher Scientific (PPD)?
This role offers the opportunity to work remotely while contributing to global pharmacovigilance operations that directly support patient safety and regulatory compliance. You will collaborate with international teams, work on enterprise-scale safety systems, and help shape the future of drug safety technology within a leading global CRO.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
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Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
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Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
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