Senior Pharmacovigilance Tech Lead — Safety Systems

Parexel; India (PA); Hybrid; INR 1,800,000 - 2,800,000; Full time

Job summary

Parexel International is seeking a Senior Safety Technology Analyst to drive the strategic implementation and operational excellence of pharmacovigilance safety technology systems. You will collaborate with Safety Operations, IT, Quality Assurance, and external auditors to ensure regulatory compliance, system optimization, and advanced safety solutions.

You will lead complex technology solutions, manage integrations, and guide change management while contributing to a growth-oriented environment

Qualifications

• 5+ years hands-on experience with safety applications across functional areas and secondary tools.
• Experience collaborating with safety operations teams to gather requirements and deliver technology solutions.
• Advanced knowledge of computer system regulations and guidance (21 CFR Part 11, EMA Annex 11, GAMP).
• Strong technical writing capability and ability to communicate complex concepts clearly to diverse audiences.

Responsibilities

• Lead the setup, configuration, and support of Parexel's safety database and related systems for new studies and ongoing operations.
• Coordinate safety database handovers from clients to Parexel and vice versa at project completion.
• Design and deliver complex integrations between Parexel safety technologies and other applications.
• Represent Safety Technology Management in cross-functional collaboration with IT, QA, and external auditors.
• Lead change management efforts in line with SDLC, including impact assessments, testing, and validation.
• Develop and deliver presentations and technical documentation for safety technology solutions.
• Lead issue resolution with IT, vendors, Safety Services staff, and clients for timely closures.
• Train and mentor team members in system administration, database support, and implementation activities.
• Collaborate with Global Pharmacovigilance Intelligence Office to ensure regulatory compliance of safety systems.

Skills

Pharmacovigilance

System administration

Regulatory compliance

Stakeholder engagement

Leadership

Education

B.E./B.Tech or equivalent in Engineering/Computer Science

Tools

Argus

Vault Safety

EDC

Safety ERP

Job description

Parexel International is seeking a Senior Safety Technology Analyst to drive the strategic implementation and operational excellence of pharmacovigilance safety technology systems. You will collaborate with Safety Operations, IT, Quality Assurance, and external auditors to ensure regulatory compliance, system optimization, and advanced safety solutions.

You will lead complex technology solutions, manage integrations, and guide change management while contributing to a growth-oriented environment