Drug Safety Associate

• Monitor incoming safety reports from multiple sources and support timely processing of pharmacovigilance data
• Perform data entry, case creation, case processing, quality checks, coding, follow-up activities, and case narrative preparation in safety databases
• Support regulatory reporting through processing, documentation, reconciliation, and tracking of safety cases and submissions
• Conduct literature searches, screen and review scientific literature, and identify potential safety information
• Submit Individual Case Safety Reports, periodic reports, and related documentation to regulatory authorities and stakeholders
• Support affiliate services, including safety information exchange, literature screening coordination, translation support, follow-up activities, and data reconciliation
• Maintain documentation, records, and project files in EDMS and eTMF environments
• Maintain regulatory databases, track submissions, support registrations, and assist with lifecycle management
• Research and update country-specific safety reporting requirements and associated records
• Participate in project meetings, training programs, audits, inspections, and departmental activities
• Escalate issues to supervisors as appropriate

Explore Patient Safety Associate I – Drug Safety Associate I at Parexel. Review requirements and application details.