Sr Programmer Analyst (PV Systems)

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profile Job Location:

Mumbai - India

profile Monthly Salary: Not Disclosed
Posted on: 15 hours ago
Vacancies: 1 Vacancy

Job Summary

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Job Description

We are seeking a highly skilled Pharmacovigilance Systems Analyst to support the operation maintenance and continuous improvement of our global drug safety systems. The ideal candidate will have strong technical expertise in pharmacovigilance (PV) systems regulatory knowledge across multiple regions and proficiency in data management and analysis tools. This is an outstanding opportunity to join a world-class team at Thermo Fisher Scientific Inc. where your contributions will help build the future of global health!

Key Responsibilities

  • Ensure compliance with global pharmacovigilance regulatory requirements and guidance documents (including Europe US and Japan).
  • Maintain proficiency in Argus Safety Database and other PV systems such as E2B gateways safety signal detection tools and other relevant technologies.
  • Support day-to-day operations troubleshooting and maintenance of safety applications to ensure reliable and compliant drug safety case processing.
  • Take part in system validation testing and deployment of Argus Safety updates workflows and business rules.
  • Develop and manage SQL queries and reports to support system setup troubleshooting and issue fixes.
  • Contribute to the development and submission of aggregate safety reports (e.g. DSURs PSURs).
  • Support and ensure adherence to change control and computer system validation (CSV) processes.
  • Collaborate effectively with cross-functional teams and external vendors to ensure smooth system operation and regulatory compliance.
  • Convey information clearly and professionally in both written and spoken English.
  • Work independently with minimal supervision managing priorities and deadlines effectively.

Qualifications

  • Bachelors or Masters degree in Computer Science or a similar field.
  • At least 5 years of experience in Pharmacovigilance or Clinical IT Operations.
  • Solid practical experience with Argus Safety and associated PV technologies.
  • Hands-on experience with SQL.
  • Excellent problem-solving analytical and communication skills.
  • Proficient in both written and oral English communication.


Required Experience:

Senior IC

Work ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob DescriptionJob DescriptionWe are seeking a highly skilled Pharmacovigilance Systems Analyst to support the operation maintenance and continuous improvement of our global drug safety systems. The ideal candidate will have strong technic...
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Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more

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