Pharmacovigilance Systems Lead — Safety Tech & Compliance

Parexel; United States; Remote; USD 120,000 - 180,000; Full time

Job summary

Parexel seeks a Senior Safety Technology Analyst to drive strategic implementation and operational excellence of pharmacovigilance safety technology systems. You will collaborate with cross‑functional teams and external auditors to ensure regulatory compliance and optimal system performance.

You’ll lead complex integrations, guide change management, and mentor staff while advancing patient safety and accelerating clinical research across Parexel’s global operations.

Qualifications

• Hands-on experience with safety applications across functional areas.
• Ability to work with safety operations to gather requirements and deliver tech solutions.
• Knowledge of computer system regulations and guidance (21 CFR Part 11, EMA Annex 11, GAMP).
• Strong technical writing and ability to communicate complex concepts clearly.

Responsibilities

• Lead setup, configuration, and support of Parexel safety systems, including new study implementations and report generation.
• Plan and execute safety database handovers between clients and Parexel at project completion.
• Design and deliver complex integrations between safety technologies and other applications.
• Collaborate with IT, QA, and auditors to ensure regulatory compliance and security standards.
• Lead change management activities aligned with SDLC, including validation and testing.
• Develop technical documentation and SOPs for safety technology solutions.
• Lead issue resolution with IT, vendors, and clients for cross‑system problems.
• Mentor and coach team members in system administration and implementation activities.
• Coordinate with Global Pharmacovigilance Intelligence Office to meet evolving safety requirements.

Skills

Pharmacovigilance systems

Safety database administration

SQL scripting

Cross-functional collaboration

Regulatory compliance

Technical writing

Education

BA/BS in Engineering or related field

Master’s degree preferred

Tools

Argus

Vault Safety

EDC

Safety ERP

Job description

Parexel seeks a Senior Safety Technology Analyst to drive strategic implementation and operational excellence of pharmacovigilance safety technology systems. You will collaborate with cross‑functional teams and external auditors to ensure regulatory compliance and optimal system performance.

You’ll lead complex integrations, guide change management, and mentor staff while advancing patient safety and accelerating clinical research across Parexel’s global operations.