This position is accountable for executing the day-to-day operations and compliance activities to maintain high-functioning PV systems across the assigned region remit. It reports directly to the PV Operational Team Lead.

• Metrics and Oversight of the Pharmacovigilance System: Support the provision of metrics to ensure oversight of PV system performance and compliance. • Quality Management System: Develop and maintain local/regional procedures in line with corporate and local requirements. Perform impact assessments of new/updated corporate policies. Assist with the PV Exception Reporting/CAPA process, business continuity plan, and local PSMF development. • ICSR Management: Record, process, conduct follow-up, and translate adverse events. Ensure local-language literature review and implement local QC procedures. Complete AE reconciliation consistent with global procedures. • Periodic Safety Reporting: Lead preparation and ensure submission of clinical periodic safety reports. • Audits and Inspection Management: Assist in managing internal PV audits, audits of affiliates, and regulatory inspections. Develop CAPA in response to observations. • Partnership with Business Partner: Ensure PV requirements are in place for safety information handling. • PV Training: Ensure training compliance with corporate and local PV requirements. • Legislation Intelligence: Monitor and assess local PV-relevant hard intelligence. • After Hours Availability & Business Continuity: Ensure 24-hour availability for AE reporting and have a Disaster Recovery Plan.

• A minimum of 2 years of experience required within pharmacovigilance or a related field. • Effective communicator, able to work in teams and a cross-functional environment. • Strong commitment to compliance with relevant rules and procedures. • Effective planning and organizational skills, with the ability to complete activities with high quality.

For more details, please refer to the company website.