Teams at Parexel

Supports pharmacovigilance and patient safety operations, including individual case safety report processing, data entry, quality checks, coding, narratives, literature review, regulatory submissions, affiliate support, reconciliation, and regulatory intelligence. Maintains safety and regulatory records in relevant systems, supports compliance with global requirements, and participates in audits, inspections, training, and project activities while escalating issues appropriately.

Manages vendor and third-party quality events, deviations, CAPAs, audits, risk assessments, due diligence, and compliance activities across clinical research and Medical Affairs. Supports third-party governance, regulatory readiness, quality documentation, process improvement, training, and stakeholder collaboration. The role requires pharmaceutical or CRO experience, knowledge of GxP, GCP, GVP, FDA, EMA, ICH, quality systems, clinical study management, external suppliers, and regulatory requirements.

Leads site activation strategy and execution for clinical trials from feasibility through activation. Coordinates critical paths, regulatory and ethics submissions, documentation, systems, timelines, risks, resources, and cross-functional teams. Manages client and investigator communications, oversees quality and compliance, mentors site activation staff, supports proposals, and drives process optimization across multiple studies and therapeutic areas.