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

• Bachelor’s or Master’s 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.