Eva Erdeljic

Background

About Eva Erdeljic

I’m a MPharm working for IQVIA as a Marketed Product Safety Manager my responsibilities include providing executive leadership of global safety organizations, expert safety guidance to customers and oversight of comprehensive service provision, to act as a single regulatory responsible person for global safety services for the organization’s clients. My experience and management skills include: Pharmacovigilance- Establishment and maintenance of PV system, PSMF - Development and maintenance of SOPs and SDEAs - PV strategy alignment with stringent PV and regulatory regulations in the EU and at national level - PV inspection readiness Quality Assurance- PV training management, providing training and guidance to all employees - Quality and compliance monitoring according to company's procedures Regulatory Affairs- Ensuring that all required regulatory submissions are prepared, submitted and approved in a timely manner to meet business targets covering all company’s products - Supporting post-approval activates - Notifying immediately on any regulatory requests, including safety labelling changes, urgent safety restriction request and external inspections - Managing communication between Regulatory, PV Department, Marketing and Artwork Department - Managing XEVMPD (Art. 57) submissions - Participating in cross- functional teams to support business of the company including involvement in planning for and execution of product launches - Monitoring emerging legislation and guidance in the EU and national level and contributing to ensure company awareness and compliance, as appropriate - Ensuring regulatory compliance and cooperation with PV and Quality Assurance - Communicating with local regulatory authorities to ensure optimal company’s and subsequently patient’s outcomes Prior to my current position, I worked at Clinres Nova as EU QPPV/Local QPPV and Senior Regulatory Affairs Associate. As a CRA at Clinres Nova, running multinational clinical trials (UK, AT, DE, HR). My responsibilities included communication with consultants and investigators, setting up and managing trial sites, training the site staff, monitoring, verification of data entries to the CRFs, writing visit reports and archiving study documentation. Through my work and active participation in the Company’s development since its founding, I proved excellent interpersonal skills and the ability to manage cross-functional teams at various levels within the organization’s clients. I’ve demonstrated leadership skills that guided my team toward achievements of corporate goals.