Romea Rusche

• Implementation of PV audit and inspection readiness • Participation in PV audits and inspections as needed • Contract review regarding PV relevant obligations • Ensuring Compliance • Training of new colleagues and vendors on Adverse Event (AE) Reporting

• Collection, Forwarding, Translation and Follow-up of AEs • Protocol Review for Investigator Initiated Trials (IITs) • Training of new colleagues and vendors on AE Reporting • Team member of a local working group with focus on improving efficiency for processes and systems

Additional Responsibilities to previous position: • Timely escalation of potential compliance issues and support in the delivery of appropriate Corrective and Preventive Actions (CAPAs) • Maintenance of awareness of local content within PV System Master File • Support to Affiliate led Organized Data Collection and to provide PV input/ Safety Reporting Training to Investigator Meetings • Team Member of Global Training Community • AE Policy Training of Non-Drug Safety Associates

Additional Responsibilities to previous position: • Oversight and Coordination of all local Reconciliation Activities • Oversight of Training of new Drug Safety hires and non-Drug Safety Staff on Adverse Event (AE) Reporting • Preparation for Audits and Inspections and participation as appropriate • Ensuring Compliance with local and international regulations, Monitoring Off-Label-Use

Additional Responsibilities to previous position: • Quality Check of Translations • Distribution and Submission of qualifying ISCRs • Local Reconciliation Activities

• ICSR processing activities including receipt and follow-up • Ensuring compliance with local and international regulations • Translation • Development and Maintenance of Local Standard Operated Procedures and Work Practices, • Documentation and Archiving

Zoologie, Medizinische Virologie, Humanbiologie