Safety Tech Analyst – Pharmacovigilance & Systems Specialist

Parexel; United States; Remote; USD 85,000 - 120,000; Full time

Job summary

Parexel, a leading clinical development partner in the United States, is seeking a Safety Technology Analyst to support pharmacovigilance operations and safety database management. You will work with cross-functional teams across Safety Services, IT, and QA to ensure regulatory compliance from study setup through closeout.

The role emphasizes configuring databases, issue resolution, and process improvements within safety technologies, with exposure to SDLC, 21 CFR Part 11, EMA Annex 11, and GAMP

Qualifications

• Experience in safety supportive applications and pharmacovigilance systems.
• Experience with computerized system validation methodologies and processes.
• Fluent in English with ability to write technical documentation and deliver clear presentations to stakeholders.
• Experience coaching and mentoring teammates in a regulatory/pharmacovigilance context.

Responsibilities

• Setup and support Parexel safety databases and systems, including new study configuration, report generation, and end-user support.
• Coordinate safety database handovers between client and Parexel at handover and at study closeout.
• Develop and maintain SOPs and controlled documents for safety technology systems.
• Deliver integration solutions between Parexel safety technologies and other applications to improve efficiency.
• Represent Safety Technology Management with cross-functional teams and auditors to ensure proper database system governance.
• Collaborate with IT, vendors, Safety Services, and clients to analyze, resolve, and close technical issues.
• Support change management activities including impact assessments, testing, and software updates per SDLC standards.
• Provide training and mentoring on safety technology systems and support activities.
• Ensure adherence to 21 CFR Part 11, EMA Annex 11, and GAMP guidelines.

Skills

Interpersonal communication

System administration

SQL scripting

English fluency

Regulatory knowledge

SDLC

Agile

Documentation

Education

BA/BS in Engineering or Computer Science

Master’s degree preferred

Tools

Argus

Vault Safety

EDC

Safety ERP

Job description

Parexel, a leading clinical development partner in the United States, is seeking a Safety Technology Analyst to support pharmacovigilance operations and safety database management. You will work with cross-functional teams across Safety Services, IT, and QA to ensure regulatory compliance from study setup through closeout.

The role emphasizes configuring databases, issue resolution, and process improvements within safety technologies, with exposure to SDLC, 21 CFR Part 11, EMA Annex 11, and GAMP