Francesca D.

Review incoming serious adverse events (SAEs) for accuracy, completeness, and potential safety issues; work closely with investigator sites/CRAs to document and clarify outstanding event issues in preparation for submitting follow-up reports; track study progress for 6 clinical trial projects; support the department by developing and implementing presentation templates for external and internal kick-off meetings (KOMs) and bid defenses (BDs) for full-service and PV-only studies; draft Safety Management Plans (SMPs) and Appendices for assigned sponsor projects; review and approve Data Management Plans; foster client relationships with consistent communication, clear expectations, and continuous feedback.

Act as a team lead and work flow manager of assigned project; supervise and guide over 25 people in Bulgaria and the Philippines; develop and utilise case processing and safety submissions working guidelines; contribute to SMP drafting; assist in audit preparations; work on quality events in case of standard deviations, utilising Corrective Action and Preventive Action (CAPA); produce key performance indicator (KPI) and compliance reports of expedited safety reporting; represent PV division at operational meetings with clients; serve as a knowledge-holder to managers.

Perform peer review of cases for quality and consistency for 15 clinical trial and post-marketing products; mentor junior colleagues on day-to-day PV activities; prepare and submit necessary reports to relevant authorities; communicate with medical staff and clients to follow-up for cases accordingly; perform data reconciliation between safety and clinical databases; maintain and update training records with up-to-date documents and procedures for the whole team.