Andrea von Ins - Sailer

• Contributes to workload monitoring activities to ensure product specific reporting obligations (e.g. Pharmacovigilance Agreements (PVA), aggregate data locks) are managed. • Monitors quality of Global Case Receipt activities and facilitate remedial actions as needed; identify and report on trends. • Key representative for site inspections and audits as identified, including interviews and provision of requested data. • Lead the development and implementation of corrective/preventative actions

•Line Manager Function •Booking of AE/SAE events •Supervision of budget •Supervision travel bookings •Supervision consultant billing, expense reports; other departmental expenses •Creation monthly Metric Report •Supervision Supplies, meetings, interview arranging, etc •Line Management of students •Developing and writing quality Documents (Standard Operating Procedures (SOP), Working Instructions (WIS) •Submission, preparation and tracking of SUSARs (Suspected Unexpected Serious Adverse Reactions)

•Determine case criteria for inclusion in the safety database •AE/ Product Quality Complaints (PQC) referral process o Reconciliation with Key stakeholders (i.e. Business Partners, PQV, Call Center) o Single and End of Study case unblinding o Monitor Global Medical Safety Operations (GMSO) global and/or local inbound mailboxes for processing of file requests or other GMSO global Mailboxes and forwarding for action as appropriate.

• Completion of initial review and seriousness assessment within ARGUS Safety, including but not limited to: • Determination of case criteria for inclusion in the safety database. • Data entry of key field • Completion of Initial Seriousness assessment. • Initiating translation request from stakeholders. • Liaising with Case Processing and key stakeholders. • Supervision of budget, travel bookings, consultant billing, expense reports. • Developing and writing quality Document (SOPs WIS)

•Line Manager Function •Booking of AE/SAE events •Administration •Process consultant billing, expense reports; other departmental expenses •Maintain the planning of absences •Supplies, meetings, interview arranging, etc •Organization of students •Assist in Logistics of GDS reports (PSUR, etc) •Assist in the preparation of summary reports for internal and external use •Assistance and contribution in developing Standard Operating Procedures (SOP) •Evacuation Officer

•Booking of AE/SAE events •Administration •Process consultant billing, expense reports; other departmental expenses •Maintain the planning of absences •Supplies, meetings, interview arranging, etc •Organization of students •Assist in Logistics of GDS reports (PSUR, etc) •Assist in the preparation of summary reports for internal and external use •Assistance and contribution in developing Standard Operating Procedures (SOP) •Evacuation Officer

Clerk in the Foreign Payments Department •registration, control and clarification of SWIFT-Orders •supervision of “EURO- SIC” •Coordinator of the apprentices

Italian, French, English, German, Latin